Medical Policy

Subject:Glucose Monitoring and Related Supplies
Policy #:  DME.00005Current Effective Date:  02/26/2009
Status:RevisedLast Review Date:  02/26/2009
Description/Scope

This document addresses devices used for glucose and home HbA1C monitoring in the management of diabetes type 1 and 2.

Note: For information regarding insulin pumps please see:

Note:  Please note that there are differences between the MiniMed Paradigm 522 and 722 model insulin pumps, the Guardian® REAL-Time Continuous Glucose Monitoring System and the MiniMed Paradigm® REAL-Time System, which incorporates both an insulin pump and continuous interstitial glucose monitoring devices. See the information below and definitions section for more complete descriptions of these devices.

Position Statement

I.   Blood Glucose Monitoring:

Medically Necessary:

FDA-approved standard blood glucose monitors are considered medically necessary for individuals with any of the following conditions:

Blood glucose monitors with certain special features to allow easy use for patients with visual impairment are considered medically necessary for patients with documented severe visual impairment (20/200 or greater severity).

The following supplies related to blood glucose monitors are considered medically necessary:

  1. Blood glucose monitoring strips (reagent strips)
  2. Lancets, including spring-powered lancets (excluding laser lancets)
  3. Other supplies, including replacement batteries, and normal, low and high calibrator solution/chips

Not Medically Necessary:

Combination glucose/fructosamine home testing devices are considered not medically necessary.

Any additional software or hardware required for downloading data from blood glucose monitors to computers is considered not medically necessary.

Blood glucose monitors for individuals with a diagnosis of "impaired glucose tolerance", "pre-diabetes" or similar terminology is considered not medically necessary.

Laser lancets are considered not medically necessary.

Blood glucose monitors with special features not directly related to diabetes care (i.e., integrated cell phones, etc.) are considered not medically necessary.

Investigational and Not Medically Necessary: 

Glucose monitors that are not FDA-approved, including, but not limited to, those using infrared spectroscopy, are considered investigational and not medically necessary.

II.    Monitoring of Glucose in the Interstitial Fluid (i.e., continuous glucose monitoring):

Medically Necessary:

Intermittent, short-term use of continuous interstitial glucose monitoring devices as an adjunct to standard care is considered medically necessary in the care of patients with Type 1 diabetes, when all of the following criteria are met:

  1. Inadequate glycemic control despite compliance with frequent self-monitoring (at least four times per day) and including fasting hyperglycemia (>150 mg/dl) or recurring episodes of severe hypoglycemia (<50 mg/dl).  This poor control is in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens to optimize care; and
  2. Insulin injections are required 3 or more times per day or an insulin pump is used for maintenance of blood sugar control; and
  3. Four or more fingersticks are required per day; and
  4. Monitoring and interpretation under the supervision of a physician; and
  5. The device is only used for seventy-two (72) consecutive hours on an appropriate, periodic basis.

Note:   Continuous interstitial glucose monitoring devices, as described above, are used episodically to direct changes in diabetic management. Given the several month timeframe to determine the efficacy of these treatment modifications, it is anticipated that when the above medical necessity criteria are met, the devices would be used up to two times in a given year.

Long-term use of continuous interstitial glucose monitoring devices as an adjunct to standard care is considered medically necessary for any of the following:

  1. Adult patients (greater than or equal to 25 years old) with Type 1 diabetes who meet the following criteria:
    1. Inadequate glycemic control, demonstrated by HbA1c measurements between 7.0% and 10.0%, despite:   
      • Compliance with frequent self-monitoring (at least four times per day); and
      • Multiple alterations in self-monitoring and insulin administration regimens to optimize care; and
    2. Insulin injections are required 3 or more times per day or a medically necessary insulin pump is used for maintenance of blood sugar control; or
  2.  Patients, regardless of age, with Type 1 diabetes who meet the following criteria:
    1. Recurring episodes of severe hypoglycemia (<50 mg/dl); and
    2. Inadequate glycemic control despite:
      • Compliance with frequent self-monitoring (at least four times per day); and
      • Multiple alterations in self-monitoring and insulin administration regimens to optimize care; and
    3. Insulin injections are required 3 or more times per day or a medically necessary insulin pump is used for maintenance of blood sugar control; or
  3. Patients with Type 1 diabetes who are pregnant, during the course of the pregnancy, who meet the following criteria:
    1. Inadequate glycemic control despite compliance with frequent self-monitoring (at least four times per day) and including fasting hyperglycemia (>150 mg/dl) or with recurring episodes of severe hypoglycemia (<50 mg/dl).  This poor control is in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens to optimize care; and
    2. Insulin injections are required 3 or more times per day or a medically necessary insulin pump is used for maintenance of blood sugar control; and
    3. Four or more fingersticks are required per day.

The use of a continuous glucose monitoring device (sensor/transmitter) with wireless communication to a compatible external insulin pump (e.g., Paradigm® REAL-Time System) is considered medically necessary when all the following have been met:

    1. The criteria for an external insulin infusion pump have been met (See CG-DME-01 External portable Continuous Insulin Infusion Pump); and
    2. The criteria for a continuous interstitial glucose monitoring device have been met  (see above); and
    3. The patient is not currently a user of
    • A functioning continuous glucose monitor; and
    • An external insulin pump without wireless integration capability.

Not Medically Necessary: 

Equipment upgrades or accessories whose sole purpose is to integrate, through wireless communication technology, an insulin pump and interstitial glucose monitor, are considered not medically necessary.

Investigational and Not Medically Necessary:

Use of continuous interstitial glucose monitoring devices and use of related supplies are considered investigational and not medically necessary for any indications not meeting the above criteria.

III. Glycated Serum Protein Monitoring

Investigational and Not Medically Necessary:

Use of hemoglobin A1c (HbA1c) or other glycosylated serum protein monitors for use in the home setting is considered investigational and not medically necessary.

Rationale

Blood Glucose Monitoring
The use of blood glucose monitors in patients with diabetes is a well-established method used to assist in the management of blood glucose levels in type 1 and type 2 and other forms of diabetes.  Numerous clinical trials and several decades of clinical experience support the use of these devices as the standard of care in this patient population.

Standard blood glucose monitoring devices usually have small display screens or other limitations that prevent visually impaired patients from being able to successfully benefit from using the device.  Newer devices designed with special features for individuals who have visual impairments, such as bigger screens, significantly improve the ability of these patients to gain benefit from blood glucose monitoring.

These blood glucose monitoring devices require many additional supplies to support their use.  Blood glucose monitoring strips, lancets, batteries and calibration materials are all necessary for the successful utilization of blood glucose monitors.  While laser lancets for blood drawing are available on the market, any clinical benefit they may have beyond standard blood collection methods has not been established in the medical literature.

Other types of blood glucose monitors have been made available on the market with such features as fingerstickless measurement, continuous blood glucose monitoring, and combination glucose and fructosamine testing.  The medical literature addressing these devices is extremely limited. 

Many types of blood glucose monitors now offer the ability to collect and transfer data to various electronic devices including computers and personal digital assistants.  While such data collection may be useful, the benefit of using electronic devices for such data collection over more traditional methods has not been established. 

For patients with impaired glucose tolerance or pre-diabetes, blood glucose monitoring has not been proven clinically useful.  Such patients are not at high risk for severe swings in blood sugar and do not require insulin injections or drugs that would necessitate the use of blood glucose monitoring devices.

Several devices using infrared spectroscopy and other methods have been suggested for the monitoring of blood glucose concentrations.  These devices have not received approval from the Food and Drug Administration of the United States and cannot be used outside a clinical trial setting.  Additionally, the medical evidence supporting their use in any setting is very limited. 

Interstitial Glucose Monitoring
The evidence from several clinical trials of continuous interstitial glucose monitoring (CIGM) has demonstrated that the devices accurately monitor blood glucose levels (Bode 2000b; Garg, 1999).  Additionally, there is adequate evidence that the short-term, periodic use of these devices allow treating physicians to correlate glucose concentration trends with daily activities.  Proper analysis of the patterns derived from the correlation between blood glucose and interstitial glucose measurements, in addition to data from a concurrent self-management diary, can impact the care of a small sub-set of patients with type 1 diabetes who continue to have inadequate glycemic control, despite optimal care and adherence (Bode, 2000a; Chase, 2003a, Chase 2003b; Garg, 2006).  

Several interstitial glucose monitoring devices are equipped with alarms that are intended to enable timely identification of hypoglycemic events.  However, a trial of 71 patients investigating the ability of the CGMS and the Guardian devices to detect hypoglycemia and to alert patients to such events reported poor results.  At a threshold of 60 mg/dl the sensitivity of the devices was only 36% and 49% respectively with a false alarm rate of 63% and 58%.  As the threshold was raised from 60 mg/dl to 100 mg/dl, sensitivity increased to 85% and 100% respectively, but at the expense of false alarm rates near 75% (Bode, 2004).  In another study of 71 subjects, the Guardian device was able to distinguish between glucose levels above and below 70 mg/dL with 67% sensitivity, 90% specificity, but with a 47% rate of false alerts (Bode, 2004).

The use of CIGM for periods longer than 72 hours at a time has been a point of debate within the clinical literature for some time.  The majority of data regarding the issue is derived from small, short-term case series studies and the availability of data from well-done large-scale randomized clinical trials is currently insufficient to allow a thorough analysis of this technology.  Thus, for most patients with diabetes, such use of these devices has not yet been demonstrated to provide any significant long-term benefits.  A large-scale trial published by Deiss and colleagues in 2006 describes a randomized controlled trial using the Guardian RT device.  The study involved 156 children and adult patients with type 1 diabetes and divided them into 3 groups; one using the Guardian RT monitor continuously, one using it biweekly for 3-day periods, and a conventional self monitoring control group.  Patients were followed for 3 months.  The authors reported that at 1 and 3 months there was a decrease in HbA1c for all groups, with greater decreases in the continuously monitored group compared to the control group (p= 0.008 at 1 month p = 0.003 at 3 months).  One episode of hypoglycemia occurred in both the continuously monitored and intermittently monitored group.  Total insulin use did not change.  This study did not specifically report on the utility of the alarm function of this device, and no conclusions can be made as to the impact of such functionality during this study.  Additionally, study participants did not register specific information regarding their self management on a daily basis, making the correlation between the use of the continuous glucose monitoring and improvements in glycemic control difficult.  The authors conclude that the results of this preliminary study are promising and that use of the Guardian RT on a periodic basis can improve blood glucose control and long-term HbA1c measurements.  However, they also note that further investigations are needed to define treatment guidelines when using continuous monitoring and that other aspects of this new technique such as long term efficacy need to be investigated.

An article by the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2008) describes a controlled trial of 322 patients with Type 1 diabetes randomized to receive either standard care with blood glucose monitoring (n=165) or to CIGM combined with blood glucose monitoring (n=157).  The study stratifies the participants into three groups; children age 8-14 years of age (n=114), adolescents and young adults age 15-24 years of age (n=100), and adults 25 years old and above (n=98).  The 25 year-old and above group demonstrated the most significant differences between the control and study populations at the 26 week follow-up.  When compared to the control group, the CIGM group in this age group had significantly better results compared to the standard care group in regard to almost all measures of glycemic control, including: overall HbA1c change from baseline to 26 weeks (P<0.001) improved, relative reduction in HbA1c of 10% or more (P=0.003), number of patients achieving target HbA1c goals less than 7.0% with no severe hypoglycemic events (P=0.006), and higher percentage of time within normal blood glucose range (P<0.001).  The data for the 8-14 year old age group demonstrated a significantly greater relative reduction in HbA1c of 10% or more (P=0.04) and a higher percentage of patients achieving a HbA1c less than 7.0% (P=0.01).  The 15 to 24 year old group had no significant differences noted.  The findings of this study suggest that CIGM may provide benefit for adults over age 24 and, to a lesser degree, children and adolescents under age 15.  The authors note that the rate of sensor use between age groups may be related to the differences in clinical outcomes.  The group with the least reported benefits, the 15-24 year olds, had only a 30% sensor use frequency.  The group with the most benefit, those 25 years of age and older, had the highest use of sensor frequency at 83%.  The group with intermediate results, 8-14 years olds, had an intermediate frequency of use of 50%.  The rate of parental supervision and support for CIGM was greater for the 8-14 year age group than for the 15-24 year old group, which may explain the higher rate of utilization and the significantly better results in younger children. The findings of this study suggest that significant benefits may be gained with CIGM when a high level of compliance with therapy is achieved. It should be noted that this study population was composed of highly motivated patients who measured their blood glucose levels 5 times a day or more, and had a beginning HbA1c of 10% or less. 

However, in the absence of clear clinical data for the wider population of patients with diabetes, there is an evolving practice pattern developing that supports the long-term use of CIGM for a small subset of patients with Type 1 diabetes who have difficulty controlling their blood glucose concentrations.  These populations include patients with Type 1 diabetes who have poor glycemic control despite optimal therapy, those with recurrent episodes of severe hypoglycemia, and those that are pregnant.

A study by Murphy and colleagues in 2008 addressed the potential benefits of CIGM in pregnant patients.  This open label randomized controlled trial included 71 women with Type 1 (n=46) and Type 2 (n=25) diabetes who were allocated to either the CIGM group (n=38) or standard care group (n=33).  The authors report that CIGM during pregnancy was associated with improved glycemic control during the third, but not the second trimester. The CIGM group had a lower HbA1c measurement during the third trimester compared to the control group (5.8% vs. 6.4% P=0.007).  Although the CIGM group also had significantly lower birth weights and risk of macrosomia, no significant differences were noted in pregnancy outcomes (delivery method, perinatal morbidity or mortality), and neonatal hypoglycemia.  The number of women enrolled in this study was small, and larger multicenter trials are required to better assess the range of potential benefits of the use of CIGM in pregnancy.

The American Diabetes Association's (ADA) Standards of Medical Care in Diabetes 2009 include recommendations supporting the use of CIGM devices for two specific populations: 1) patients aged 25 years or older who have Type 1 diabetes and poor glycemic control despite optimal therapy, and 2) patients with recurrent episodes of severe hypoglycemia.  These Standards also state that there is some evidence that CIGM may be useful for lowering HbA1c in children and teens who have difficulty in controlling blood sugar concentrations, although they concede that the evidence for such use is not as strong as for older patients.

Additionally, when discussing continuous interstitial glucose monitoring technology, the 2009 ADA Standards indicate that these systems require calibration with SMBG measurements, and that blood glucose measurements, not CIGM measurements, are recommended for making treatment decisions.  Thus these devices should be used only by those patients with Type 1 diabetes who are currently performing regular, frequent self monitoring of their blood glucose concentrations. 

On April 7, 2006 the FDA granted approval for the MiniMed Paradigm® REAL-Time System.  This system involves the use of a Medtronic MiniMed Paradigm insulin pump (models 522, 722 or newer) and a Medtronic MiniMed continuous interstitial glucose sensor and MiniLink™ REAL-Time transmitter.  These devices are connected wirelessly via radio frequency to allow interstitial glucose data to be collected and displayed by the Paradigm insulin pump-control unit.  The sensor and transmitter devices are available separately.  The Paradigm insulin pump can be used as a stand-alone continuous insulin infusion pump or integrated with continuous interstitial glucose monitoring as a component of the MiniMed Paradigm REAL-Time System.  The Paradigm REAL-Time System includes special features like real-time read-out and glucose trend graphing and indicators. 

While there is evidence to demonstrate that both external insulin infusion pumps and continuous interstitial glucose monitors are useful in the management of select patients with diabetes, there is no current evidence available that these combined devices provide any health outcomes benefit over the use of two separate units used simultaneously.  The use of a combined device (e.g. Paradigm REAL-Time System) for qualifying patients new to both insulin infusion and continuous glucose monitoring therapy is reasonable as it eliminates the need to purchase two separate monitor/control devices to be worn on the belt.  However, upgrades of functioning and warranted pump or monitoring equipment for the convenience of using a single external insulin pump and glucose monitor device is considered not medically necessary.

Glycosylated Serum Protein Monitoring
The measurement of hemoglobin A1c (HbA1c, a glycosylated hemoglobin) levels is a standard measure of blood glucose control over time.  It is routinely used to evaluate and direct diabetic care and control of HbA1c concentrations is related to complications and outcomes in patients with diabetes.  The 2009 American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommend that HbA1c be tested at least twice a year in diabetics who are meeting treatment goals and whose therapy is stable, and quarterly in those who are not meeting goals or whose therapy is changing.  These recommendations are based on expert consensus or clinical experience.  There is no evidence to suggest that more frequent HbA1c measurement is helpful in the management of patients with diabetes.

Unlike home glucose monitoring which gives an instantaneous reading of blood sugar levels at a single point in time and is used to alter diabetic treatment in real time, measurement of HbA1c is an indicator of blood glucose control over a long period of time and the recommended frequency of testing is in the range of every 3 or 6 months depending on control.  Thus, there is no value in measuring HbA1c multiple times in the course of a day or week. Finally, home HbA1c monitoring has not been established to have any role in diabetes care and no authoritative organization recommends such testing.

Background/Overview

Diabetes is characterized by high blood sugar levels related to problems with the body's ability to react to or produce insulin, a substance created in the pancreas.  Insulin is a vital part of the body's mechanism for using blood glucose to produce energy.  According to the American Diabetes Association, approximately 17 million people in the United States have diabetes.  An estimated 11.1 million people have been diagnosed while 5.9 million people are unaware that they have the disease.

There are three major types of diabetes:

Diabetes may lead to very serious health problems including an increased risk for heart attack, stroke, and complications related to poor circulation such as nerve damage, kidney failure, and blindness.  One of the most common complications of diabetes is diabetic neuropathy or damage to the nerves.  Problems may develop in the feet from nerve damage as a result of neuropathy or from poor blood flow.  Patients with diabetes are also at a higher risk for gum disease and other mouth-related problems.  Careful regulation and monitoring of blood glucose levels have been shown to prevent or slow the progression of these and other diabetes-related conditions.

Blood Glucose Monitors

A blood glucose monitor is a portable battery-operated meter used to determine the level of blood sugar (glucose).  Using a lancet, the individual obtains a drop of blood, which is placed on a special strip and inserted into the machine.  The monitor determines the blood glucose level, and a numerical reading is displayed.  Based on the glucose level, the individual may adjust his/her medication or eating habits within the limits set by the physician.

Blood glucose monitoring systems are also available for use by patients who are visually impaired.  These monitors have special voice synthesizers, timers, and specific supplies to enable visually impaired patients to use the equipment without assistance.  Other monitors feature components that can connect to a personal computer and graph blood sugar readings over time.

There are many new nonstandard forms of glucose monitors; among them are monitors that do not require a drop of blood but can "read" glucose levels through the skin, and small, implanted sensors that can monitor glucose levels every 5 minutes for three days.  One monitor, the Duet system, can monitor blood glucose as well as fructosamine protein levels, another indicator of blood sugar levels.

Other Glucose Monitoring Devices

There are other interstitial glucose monitoring devices currently under investigation that use other methods of glucose collection and analysis.  These devices have yet to receive approval by the Food and Drug Administration.

Interstitial Glucose Monitors

Devices are now available that continuously monitor the glucose concentrations in the fluid in between the body's cells, also known as interstitial fluid.  The devices function on the scientific principle of using a glucose oxidase enzyme reaction to measure glucose.  The continuous monitoring of glucose levels has been an important adjunct to blood glucose monitoring in patients with diabetes who suffer from undetected hypoglycemic events or with brittle control of their blood glucose levels despite optimal care.  Continuous interstitial glucose monitoring (CIGM) devices are designed to electronically store the data collected for later downloading to a computer for trend analysis by a physician.  These data sets may be used to identify ways to improve patient care by altering diet, exercise, or medication types or timing.  Some devices also have functions such as real-time read-out displays of recent measurements, hypoglycemia alarms, wireless connectivity, and others.

It must be noted that there are a variety of interstitial glucose monitoring devices available.  These devices can be divided into those intended for intermittent 72 hour monitoring and those intended for longer-term use.  The devices intended to be used intermittently should be dispensed and their results interpreted by a physician.

CIGM devices use a small tube inserted beneath the skin to sample the intracellular fluid for testing.  There are several CIGM devices commercially available including:

Additionally, MiniMed markets the Paradigm® REAL-Time System, which includes several components,, a MiniMed Paradigm insulin pump and a compatible REAL-Time Continuous Glucose Monitor (sensor and transmitter).  These devices are available separately, and neither portion of the system requires the presence of the other to function properly. 

It should be noted that the GlucoWatch Biographer CIGM device is no longer available in the U.S.

Hemoglobin A1c Measurement

The measurement of certain glycosylated serum proteins had been used as an indicator of long-term blood sugar concentrations and control.  The most important of these is hemoglobin A1c (HbA1c).  The current American Diabetes Association (ADA) guidelines for the monitoring of HbA1c recommends HbA1c measurements at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control) and quarterly in patients whose therapy has changed or who are not meeting glycemic goals (ADA, 2009). The ADA has set a HbA1c concentration of 7% as the goal for patients with diabetes.  When a patient has a measurement greater than 7% it is an indicator that the patient's blood sugar concentrations are not adequately controlled under their current care regimen and alterations in their diet, exercise level and drug regimen is warranted.

Definitions

Blood Glucose: a sugar that is present in the bloodstream

Continuous Glucose Monitoring System (CGMS®) iPro™ Continuous Glucose System: a device that measures the sugar concentration in fluid in between cells below the skin as an aid in diabetes management; this device is intended to be used for three day period; once this period is up the device is returned to the doctor's office and the data collected are analyzed; treatment changes may be made as a result of the findings 

DexCom™ STS™ Continuous Interstitial Glucose Monitor: a device that measures the sugar concentration in fluid in between cells below the skin as an aid in diabetes management; this device features an alarm function, digital real-time readout and a cordless data-recoding device 

Fingersticks: a process where a patient with diabetes uses a sterile lancet to prick their finger for the purpose of drawing blood for blood glucose measurements

Fructosamine: molecules formed by the linking of blood sugars onto protein molecules in the bloodstream; this process is affected by the levels of blood glucose and has been proposed as an indicator of blood glucose levels over a few weeks' time

Glucose: a form of sugar required for proper functioning of the body

Glycemic Control: control of blood glucose levels

Hemoglobin A1c (HbA1c): a protein in red blood cells that on occasion bonds with glucose in the blood; measurements of hemoglobin A1c concentrations are used as an indicator of a person's average blood glucose level for the span of the cell's life (about 4 months)

Hyperglycemia: blood glucose levels higher than the normal range

Hypoglycemia: blood glucose levels lower than the normal range

Impaired Glucose Tolerance (IGT) (also known as 'Impaired Fasting Glucose' or 'Pre-Diabetes'): a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes 

Infrared Spectroscopy: a method proposed for the measurement of blood glucose levels using an infrared light-based device

Insulin: a substance normally produced by the body that takes glucose from the blood and makes glucose usable by the cells of the body

Interstitial Glucose: glucose that is found in the fluid between cells, outside the blood vessels

Invasive: involving puncture or incision of the skin

Medtronic CGMS® iPRO™ Continuous Glucose Monitoring System:  a continuous glucose monitoring system for periodic monitoring of interstitial glucose levels by a physician; this system is comprised of two separate components, a glucose sensor and a data recorder; the sensor and recorder are attached to each other and affixed to the skin of the abdomen; data is collected by recorder for up to 72 hours, and is then downloaded to a computer in the physician's office for analysis

 Medtronic Guardian® REAL-Time Continuous Glucose Monitoring System:  a continuous glucose monitoring system for either periodic or continuous monitoring of interstitial glucose levels; this system is comprised of three separate components, a glucose sensor, a MiniLink transmitter and a receiver/monitor device attached to the belt; the sensor and transmitter are attached to each other and affixed to the skin of the abdomen; data collected by sensor is then wirelessly transmitted to the receiver/monitor device which then displays it in real-time; the receiver/monitor can also display trend information and sound alerts when glucose measurements are out of a pre-set range

Medtronic MiniMed Paradigm® Model Insulin Pump: an external insulin pump model; some Paradigm model pumps (models 522, 722 and newer) have the capability of wireless communication with the MiniMed continuous interstitial glucose sensor/transmitter devices, which are available separately from the Paradigm pump, or may be purchased as a combined system that is marketed under the name MiniMed Paradigm REAL-Time System (see below).  Note that all Medtronic MiniMed Paradigm® insulin pumps currently marketed in the US are compatible with MiniMed interstitial glucose sensor/transmitter devices.

Medtronic MiniMed Paradigm® REAL-Time System: a device that integrates a Medtronic MiniMed Paradigm model external insulin pump (models 522, 722 and newer) with a Medtronic MiniMed continuous interstitial glucose sensor and transmitter via wireless communication technology;  this system has all the functionality of the  Paradigm external insulin pump, as well as those described above for the Guardian REAL-Time Continuous Glucose Monitoring System; the system is comprised of three components, a glucose sensor, a MiniLink transmitter and the Paradigm pump, which acts as the receiver/monitor device for the continuous glucose monitoring data.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

I.  Blood Glucose Monitors and Supplies 

When services are Medically Necessary:

HCPCS 
A4253Blood glucose test or reagent strips for home blood glucose monitor
A4255Platforms for home blood glucose monitor
A4256Normal, low and high calibrator solution/chips
A4258Spring-powered device for lancet, each
A4259Lancets
A9275Home glucose disposable monitor, includes test strips
E0607Home blood glucose monitor
E2100Blood glucose monitor with integrated voice synthesizer
E2101Blood glucose monitor with integrated lancing/blood sample
  
ICD-9 Diagnosis 
 All diagnoses
 When services are Not Medically Necessary: 
HCPCS 
A4257Replacement lens shield cartridge for use with laser skin piercing device
E0620Skin piercing device for collection of capillary blood, laser
  
ICD-9 Diagnosis 
 All diagnoses

II.  Continuous Glucose Monitoring 

When Services may be Medically Necessary, when criteria are met: 

CPT 
95250Ambulatory 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
95251Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report
  
HCPCS 
A9276Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one 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
S1030Continuous non-invasive glucose monitoring device, purchase [Note: no longer marketed]
S1031Continuous non-invasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor [Note: no longer marketed]
  
ICD-9 Diagnosis 
250.00-250.93Diabetes mellitus
648.00-648.04Diabetes mellitus complicating pregnancy

When services are Not Medically Necessary:

For the HCPCS procedure and diagnosis codes listed above, when the code describes a procedure indicated in the Position Statement section as not medically necessary.

When services are Investigational and Not Medically Necessary:

For the procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

III.  Glycated Serum Protein Monitoring 

When services are Investigational and Not Medically Necessary:

HCPCS 
 No specific code for glycosylated serum protein monitors for home use
  
ICD-9 Diagnosis 
 All diagnoses
References

Peer Reviewed Publications:

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  2. Bantle JP, Thomas W. Glucose measurement in patients with diabetes mellitus with dermal interstitial fluid. J Clin Lad Med. 1997; 130:436-441.
  3. Bode BW. Clinical utility of the continuous glucose monitoring system. Diabetes Tech Therapeutics. 2000a; 2(S1):S35-S41.
  4. Bode BW.  Using the continuous glucose monitoring system to improve the management of type 1 diabetes. Diab Tech Therapeutics. 2000b; 2(S1):S43-S48.
  5. Bode B, Gross K, Rikalo N, et al. Alarms based on real-time sensor glucose values alert patients to hypo-and hyperglycemia: The guardian continuous monitoring system. Diabetes Technol Ther. 2004; 6(2):105-113.
  6. Bode W, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: A pilot study. Diabetes Res Clin Pract. 1999; 46:183-190.
  7. Boland E, Monsod T, DeLecia M, et al. Limitations of conventional methods of self-monitoring of blood glucose. Diabetes Care. 2001; 24:1858-1862.
  8. Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care. 1999; 22(11):1785-1789.
  9. Chase HP, Wightman C, Klingensmith G, et al. Use of the GlucoWatchÒ in children with type I diabetes.  Pediatrics. 2003a; 111:790-794.
  10. Chase HP, Kim LM, Owen SL, et al. Continuous glucose monitoring in children with type 1 diabetes. Pediatrics. 2001; 107:222-226.
  11. Chase HP, Roberts MD, Wightman C, et al. Use of the glucowatch biographer in children with Type 1 diabetes. Pediatrics. 2003b; 111(4 Pt 1):790-794.
  12. Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring system during controlled hypoglycemia in health volunteers.  Diabetes Tech Therapeutics. 2002; 4(5):607-613.
  13. Deiss D, Hartmann R, Schmidt J, Kordonouri O. Results of a randomised controlled cross-over trial on the effect of continuous subcutaneous glucose monitoring (CGMS) on glycaemic control in children and adolescents with type 1 diabetes.  Exp Clin Endocrinol Diabetes. 2006 114: 63-67.
  14. Deiss D, Bolinder Jan, Jean-Pierre Riveline J, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006; 29:2730-2732.
  15. Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the glucowatch G2 biographer and the continuous glucose monitoring system during hypoglycemia: experience of the Diabetes Research in Children Network. Diabetes Care. 2004; 27(3):722-726.
  16. Diabetes Control and Complication Trial Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes. NEJM. 1993; 329:977-986.
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  20. Fineberg SE, Bergenstal RM, Bernstein RM, et al. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care. 2001; 24(7):1217-1220.
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  22. Gandrud LM, Paguntalan HU, Van Wyhe MM, et al. Use of the Cygnus GlucoWatch biographer at a diabetes camp. Pediatrics. 2004; 113(1 Pt 1):108-111.
  23. Garg SK, Potts Ro, Ackerman, NR, et al. Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with Type 1 diabetes. Diabetes Care. 1999; 22(10):1708-1714.
  24. Garg SK, Schwartz S, Edelman SV. Improved glucose excursions using an implantable real-time continuous glucose sensor in adults with type 1 diabetes. Diabetes Care. 2004; 27(3):734-738.
  25. Garg S, Zisser H, Schwartz S, et al.  Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29(1):44-50.
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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality. Point of care testing of hemoglobin A1c. August 30, 2005.  Available at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=35. Accessed on January 13, 2009.
  2. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocrine Prac. 2007; 13(Suppl 1):1-68.
  3. American Diabetes Association. Standards of Medical Care in Diabetes—2009. Diabetes Care. 2009; 32(Suppl 1):S13-S61. Available at: http://care.diabetesjournals.org/cgi/reprint/32/Supplement_1/S13.  Accessed on January 12, 2009.
  4. American Diabetes Association. Gestational diabetes mellitus.  Diabetes Care. 2002; 26(Suppl 1):S103-105.
  5. American Diabetes Association. Tests of Glycemia in Diabetes. Diabetes Care. 2002; 26(Suppl 1):S106-108.
  6. American Diabetes Association. Third-Party Reimbursement for Diabetes Care, Self-Management Education, and Supplies Diabetes Care. 2002; 26(Suppl 1):S143-144.
  7. American Diabetes Association. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2002; 26(Suppl 1):S5-20.
  8. Blue Cross Blue Shield Association. Use of intermittent or continuous interstitial fluid glucose monitoring in patients with diabetes mellitus. Technology Evaluation Center Volume 18, No. 16.December 2003.
  9. Canadian Coordinating Office for Health Technology. Continuous glucose monitoring in the management of diabetes mellitus. Issues in Emerging Health Technologies. May 2002; Issue 32.
  10. Centers for Medicare and Medicaid Services. National Coverage Determination for Home Blood Glucose Monitors. NCD #40.2. Effective April 27, 1995.  Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on January 13, 2009.
  11. Centers for Medicare and Medicaid Services. National Coverage Determination for Insulin Syringe. NCD #40.4. Effective date not posted. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd.   Accessed on January 13, 2009.
  12. Hayes, Inc. Medical Technology Directory. Continuous glucose monitoring systems. Hayes Inc. Lansdale, PA. Dec 17, 2008.
Web Sites for Additional Information
American Diabetes Association. Available at www.diabetes.org. Accessed on January 20, 2009.
Index
A1cNow +®
BioRad MicroMat™ II HbA1c Monitor
Cholestech GDX™HbA1c Test
CGMS®
CGMS® iPro™ Recorder
Continuous Glucose Management System® CGMS®
DexCom™ STS-7® Continuous Glucose Monitoring System
DexCom™ STS™ Continuous Interstitial Glucose Monitor
DuoCare
FreeStyle Navigator™
GDX™ HbA1c Test
GlucoWatch®
Glycosal II HbA1c Test
Guardian® RT Continuous Glucose Monitoring System
Guardian® Telemetered Glucose Monitoring System (TGMS)
Metrika A1cNow +®
MicroMat® II HbA1c Monitor
Paradigm® REAL-Time System
Provalis Glycosal® II HbA1c Test
Seven System
STS-7®
The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
Document History
StatusDateAction
Reviewed02/26/2009Medical Policy & Technology Assessment Committee (MPTAC) review.   Added to medically necessary section continuous glucose monitoring for patients with inadequate glycemic control when criteria are met. Updated Rationale and Reference sections
Reviewed11/20/2008MPTAC review. Clarified criteria for long-term continuous interstitial glucose monitoring. Updated Rationale and Reference sections.  Updated coding section with 01/01/2009 CPT changes.
Revised05/15/2008MPTAC review. Added medically necessary statement regarding radio frequency (wireless) integrated systems (e.g., Paradigm System) for the new start patient meeting criteria for both continuous glucose monitors and pumps. Added new not medically necessary statement regarding the use of equipment upgrades or accessories whose sole purpose is to integrate an insulin pump and interstitial glucose monitor.  Revised Rationale, Definitions, Coding and Reference sections.
Revised02/21/2008MPTAC review. Removed word "non-invasive" from interstitial glucose monitoring statement.  Added patients with recurrent hypoglycemia and patients with type 1 diabetes who are pregnant as medically necessary indications for continuous interstitial glucose monitoring used longer than 72 hours.  Updated Rationale, Background, Coding and Index sections.
Revised11/29/2007

MPTAC review. Clarified interstitial glucose monitoring investigational and not medically necessary statement to clarify that the use of continuous interstitial glucose monitoring devices that are intended for use greater than three days is considered investigational/not medically necessary.  The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."  Updated Rationale, Background, and Reference sections.  Coding section updated with 01/01/2008 HCPCS changes.

Revised05/17/2007

MPTAC review. Clarified statement regarding hemoglobin A1c monitors in the home.  Updated Rationale, Reference, Coding and Index sections.

Revised12/07/2006

MPTAC review. Added additional criteria for medically necessary use of interstitial glucose monitors. Added position statement considering the Paradigm® REAL-Time System as investigational/ not medically necessary. Updated Rationale, Background, and Index sections.

Revised09/14/2006MPTAC review. Added Guardian® RT Continuous Glucose Monitoring System and the DexCom™ STS™ Continuous Interstitial Glucose Monitor to the continuous glucose monitoring MN statement. Updated rationale, background and reference sections.
Reviewed03/23/2006MPTAC annual review. References and coding updated. 
 01/01/2006Updated coding section with 01/01/2006 CPT/HCPCS changes
 11/18/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised04/28/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review DateDocument NumberTitle
Anthem, Inc.04/28/2004DME.00005Glucose Monitoring and Related Supplies
WellPoint Health Networks, Inc.09/23/20042.06.12Continuous Monitoring of Glucose in the Interstitial Fluid