mp-038
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Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid

Policy Number: MP-038

Latest Review Date: August 2021                                                                                                                                                                       

Category: DME   

POLICY:

Dates of service October 1, 2021 and after:

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

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

OR

  • Regular insulin within the past 90 days.

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

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

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

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

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

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

For coverage information regarding Medtronic’s MiniMed 630G and 670G/770G, refer to medical policy #636 Artificial Pancreas Device Systems.

Dates of service prior to October 1, 2021:

Intermittent Monitoring

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

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

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

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

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

Continuous Monitoring

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

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

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

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

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

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

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

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

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

For coverage information regarding Medtronic’s MiniMed 630G and 670G, refer to medical policy #636 Artificial Pancreas Device Systems.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 5-10 minutes). The devices measure glucose in the interstitial fluid and are approved as adjuncts to traditional self-monitoring of blood glucose levels. Devices can be used on a long-term (continuous) or short-term (often referred to as intermittent) basis.

Blood Glucose Control

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

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

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

Management

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

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

Approved devices now include devices indicated for pediatric use and those with more advanced software, more frequent measurements of glucose levels, or more sophisticated alarm systems. Devices initially measured interstitial glucose every 5 to10 minutes and stored data for download and retrospective evaluation by a clinician. With currently available devices, the intervals at which interstitial glucose is measured range from every 1-2 minutes to 5 minutes, and most provide measurements in real-time directly to patients. While CGM potentially eliminates or decreases the number of required daily fingersticks, it should be noted that, according to the Food and Drug Administration labeling, some marketed monitors are not intended as an alternative to traditional self-monitoring of blood glucose levels but rather as adjuncts to monitoring, supplying additional information on glucose trends not available from self-monitoring. The devices must be calibrated twice daily with blood glucose measurements from fingersticks, and are less reliable when used after exercise or post-prandial. Devices may be used intermittently (i.e., for periods of 72 hours) or continuously (i.e., on a long-term basis).

KEY POINTS:

The most recent literature search was performed through August 2021. Following is a summary of the key literature to date.

Summary of Evidence:

Type 1 Diabetes

For individuals with type 1 diabetes who are willing and able to use the device, and have adequate medical supervision, who receive long-term CGM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Systematic reviews have generally found that at least in the short-term, long-term CGM resulted in significantly improved glycemic control for adults and children with type 1 diabetes, particularly highly compliant patients. A 2017 individual patient data analysis, pooling data from 11 RCTs, found that reductions in HbA1c levels were significantly greater with real-time CGM than with a control intervention. Two RCTs in patients who used multiple daily insulin injections and were highly compliant with CGM devices during run-in phases found that CGM was associated with a larger reduction in HbA1c levels than previous studies. One of the 2 RCTs prespecified hypoglycemia-related outcomes and reported that time spent in hypoglycemia was significantly less in the CGM group. One RCT in pregnant women with type 1 diabetes, which compared real-time CGM with self-monitoring of blood glucose, has also reported a difference in change in HbA1c levels, an increased percentage of time in the recommended glucose control target range, a smaller proportion of infants who were large for gestational age, a smaller proportion of infants who had neonatal intensive care admissions lasting more than 24 hours, a smaller proportion of infants who had neonatal hypoglycemia requiring treatment, and reduced total hospital length of stay all favoring CGM. The evidence is sufficient to determine that the long-term use of CGM provides an improvement in net health outcomes for persons with type 1 diabetes mellitus.

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

Type 2 Diabetes

For individuals with type 2 diabetes who receive long-term CGM, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Most RCTs of CGM in patients with type 2 trials found statistically significant benefits of CGM regarding glycemic control. However, the degree of HbA1c reduction and the difference in HbA1c reduction between groups might not be clinically significant. Moreover, additional evidence would be needed to show what levels of improvements in HbA1c levels over the short-term would be linked to meaningful improvements over the long-term in health outcomes such as diabetes-related morbidity and complications. Also, the variability in entry criteria as well as among interventions makes it difficult to identify an optimal approach to CGM use; the studies used a combination of intermittent and continuous monitoring with a review of data in real-time or at study visits only. Only the DIAMOND RCT (n=158) has used real-time CGM in type 2 diabetes. Selected patients were highly compliant during a run-in phase. The difference in change in HbA1c levels from baseline to 24 weeks was -0.3% favoring CGM. The difference in the proportion of patients with a relative reduction in HbA1c level by 10% or more was 22% favoring CGM. There were no differences in the proportions of patients with an HbA1c level of less than 7% at week 24. There were no events of severe hypoglycemia or diabetic ketoacidosis in either group. The treatment groups did not differ in any of the QOL measures. RCTs using flash glucose-sensing technology as a replacement for SMBG for the management of insulin-dependent treated type 2 diabetes found no difference in HbA1c change at 6 and 12 months between groups. However, time in severe hypoglycemia (<45mg/dL) was reduced for intervention participants. Two trials of CGM have enrolled pregnant women with type 2 diabetes, but the total number of women with type 2 diabetes included in both trials is only 58. One study reported a difference in HbA1c levels at 36 weeks, and the proportion of infants that were large for gestational age (>90th percentile) favored CGM while the second study did not. Neither trial reported analyses stratified by diabetes type. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with type 2 diabetes who are willing and able to use the device and have adequate medical supervision and who experience significant hypoglycemia on multiple daily doses of insulin or an insulin pump in the setting of insulin deficiency who receive long-term (continuous) glucose monitoring, the evidence includes a systematic review and non-randomized study with 12-month follow-up. Relevant outcomes are the frequency of and time spent in hypoglycemia, the incidence of hypoglycemic episodes, complications of hypoglycemia, and QOL. The available studies demonstrate that CGM can significantly reduce time in hypoglycemia and frequency of hypoglycemia events both during the day and at night. At 12-month follow-up, hypoglycemic events were reduced by 40.8% to 61.7% with a greater relative reduction in the most severe thresholds of hypoglycemia. The published evidence supports a meaningful improvement in the net health outcome. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with type 2 diabetes who receive short-term CGM monitoring, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, QOL, and treatment-related morbidity. Systematic reviews of 3 to 4 RCTs have found statistically significant benefits from CGM regarding glycemic control. However, the degree of HbA1c reduction and the difference in HbA1c reductions between groups may not be clinically significant. Also, the limited number of RCTs and variability among interventions make it difficult to identify an optimal approach to CGM or a subgroup of type 2 diabetes patients who might benefit. Moreover, studies of CGM in patients with type 2 diabetes have generally not addressed the clinically important issues of severe hypoglycemia and diabetic complications. Very few pregnant women with type 2 diabetes have been included in RCTs. Limitations of the published evidence preclude determining the effects of the technology on net health outcome. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Gestational Diabetes

For individuals who are pregnant with gestational diabetes who receive long-term (continuous) or short-term (intermittent) glucose monitoring, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, quality of life, and treatment-related morbidity. In the RCT, the type of CGM was unclear. Trial reporting was incomplete; however, there was no difference between the groups for the majority of the reported outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Association of Clinical Endocrinologists and American College of Endocrinology

In 2020, the AACE and the ACE 2015 Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan was supplemented by an AACE/ACE Consensus Statement on Comprehensive Type 2 Diabetes Management. It is recommended that therapy be evaluated regularly including the results of A1C, SMBG records (fasting and postprandial) or continuous glucose monitoring tracings. The statement supports consideration of the use of personal CGM devices for those patients who are on intensive insulin therapy (three to four injections/day or on an insulin pump), for those with a history of hypoglycemia unawareness, or those with recurrent hypoglycemia. Regarding the duration of use the statement reads; “While these devices could be used intermittently in those who appear stable on their therapy, most patients will need to use this technology on a continual basis".

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2016) updated its guidance on the diagnosis and management of type 1diabetes in adults. The guidance stated that real-time CGM should not be offered “routinely to adults with type 1 diabetes” but that it can be considered in the following:

"...adults with type 1 diabetes who are willing to commit to using it at least 70% of the time and to calibrate it as needed, and who have any of the following despite optimized use of insulin therapy and conventional blood glucose monitoring:

  • More than 1 episode a year of severe hypoglycemia with no obviously preventable precipitating cause.
  • Complete loss of awareness of hypoglycemia.
  • Frequent (more than 2 episodes a week) asymptomatic hypoglycemia that is causing problems with daily activities.
  • Extreme fear of hypoglycemia.
  • Hyperglycaemia (HbA1c [hemoglobin A1c] level of 75 mmol/mol [9%] or higher) that persists despite testing at least 10times a day. Continue real‑time continuous glucose monitoring only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more."

American Diabetes Association

The American Diabetes Association (2020) “Standards of Medical Care in Diabetes: Diabetes Technology," included the following statement in the chapter on glycemic targets:

"Continuous glucose monitoring (CGM) also has an important role in assessing the effectiveness and safety of treatment in many patients with type 1 diabetes, and limited data suggest it may also be helpful in selected patients with type 2 diabetes, such as those on intensive insulin regimens."

The Standards also state that the technology has evolved rapidly in both accuracy and affordability and that data provided by CGM "will allow the provider to determine time in range (TIR) and to assess hypoglycemia, hyperglycemia, and glycemic variability", noting that there is a strong correlation between TIR and an A1C.

Endocrine Society

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

6. "Real-time continuous glucose monitors in adult outpatients

6.1 We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM [type 1 diabetes mellitus] who have A1C levels above target and who are willing and able to use these devices on a nearly daily basis.

6.2 We recommend RT-CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on an early daily basis.

Use of continuous glucose monitoring in adults with type 2 diabetes mellitus [T2DM]

6.3 We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels ≥7%and are willing and able to use the device."

International Consensus on Time in Range

In 2019, consensus recommendations on clinical targets for CGM data interpretation were published and endorsed by the American Diabetes Association, American Association of Diabetes Educators, European Association for the Study of Diabetes, Foundation of European Nurses in Diabetes, International Society for Pediatric and Adolescent Diabetes, JDRF, and Pediatric Endocrine Society.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

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

APPROVED BY GOVERNING BODIES:

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

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

Flash glucose monitors (e.g. FreeStyle Libre, Abbott) use intermittent scanning and do not have continuous or real-time alerts.

Table 1. CGM Systems Approved by the Food and Drug Administration

Device

Manufacturer

Approval

Indications

Continuous Glucose Monitoring System (CGMS®)

MiniMed

1999

3-d use in physician's office

GlucoWatch G2® Biographer

 

2001

Not available since 2008

Guardian®-RT (Real-Time) CGMS

MiniMed (now Medtronic)

2005

 

Dexcom® STS CGMS system

Dexcom

2006

 

Paradigm® REAL-Time System (second-generation called Paradigm Revel System)

MiniMed (now Medtronic)

2006

Integrates CGM with a Paradigm insulin pump

FreeStyle Navigator® CGM System

Abbott

2008

 

Dexcom® G4 Platinum

Dexcom

2012

Adults ≥18 y; can be worn for up to 7 d

   

2014

Expanded to include patients with diabetes 2-17 y

Dexcom® G5 Mobile CGM

Dexcom

2016a

Replacement for fingerstick blood glucose testing in patients ≥2 y. System requires at least 2 daily fingerstick tests for calibration purposes, but additional fingersticks are not necessary because treatment decisions can be made based on device readings5,

Dexcom® G6 Continuous Glucose Monitoring System

Dexcom

2018

Indicated for the management of diabetes in person’s age ≥2 years.

Intended to replace fingerstick blood glucose testing for diabetes treatment decisions.

Intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. with 10-day wear

Freestyle Libre®Flash Glucose Monitoring System

Abbott

2017

Adults ≥18 y. Indicated for the management of diabetes and can be worn up to 10 days It is designed to replace blood glucose testing for diabetes treatment decisions.

Freestyle Libre® Flash Glucose Monitoring System

Abbott

2018

Adult’s ≥18 y.

Extended duration of use to 14 days

Freestyle® Libre 2 Flash Glucose Monitoring System

Abbott

June 2020

Children ≥ 4 years of age

Guardian Connect

Medtronic MiniMed

2018

Adolescents and adults (14-75 years)

Continuous or periodic monitoring of interstitial glucose levels.

Provides real-time glucose values, trends, and alerts through a Guardian Connect app installed on a compatible consumer electronic mobile device

Eversense Continuous Glucose Monitoring System

Senseonics

2018

2019

Adult’s ≥18 y.

Continually measuring glucose levels up to 90 days.

Use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.

Adult’s ≥18 y.

Continually measuring glucose levels up to 90 days.

Indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.

Historical data from the system can be interpreted to aid in providing therapy adjustments.

CGM: continuous glucose monitoring.

a As a supplement to the G4 premarketing approval.

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

BENEFIT APPLICATION:

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

ITS: Home Policy provisions apply

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

CURRENT CODING:

CPT codes:

95249

Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; patient-provided equipment, sensor placement, hook-up, calibration of monitor, patient training, and printout of recording

95250

Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of  72 hours; physician or other qualified health care professional (office) provided equipment, sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording

95251

Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; analysis, interpretation and report

 

99091

Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time

0446T

Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training

0447T

Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision

0448T

Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation

 

 

 

HCPCS:

A9276

Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one unit = 1 day supply

A9277

Transmitter; external, for use with interstitial continuous glucose monitoring system

 

A9278

Receiver (monitor); external, for use with interstitial continuous glucose monitoring system

A9999

Miscellaneous DME supply, accessory, and/or service component of another HCPCS code

E1399

Durable medical equipment, miscellaneous

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.

S1030

Continuous noninvasive glucose monitoring device purchase (for physician interpretation of data, use CPT code)

S1031

Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code)

Continuous glucose monitoring (CGM) systems measure glucose in interstitial fluid, rather than capillary blood. Because they do not measure blood glucose, different HCPCS and CPT coding are used for these systems and supplies (HCPCS codes A9276-A9278 and K0553-K0554).

REFERENCES:

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  20. Blue Cross Blue Shield Association Technology Evaluation Criteria (TEC) Assessment. Use of intermittent or continuous interstitial fluid glucose monitoring in patients with diabetes mellitus. TEC Assessments 2003; Volume 18, Tab 16.
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  27. Food and Drug Administration (FDA). Summary of Safety and Effectiveness (SSED): Dexcom G5 Mobile Continuous Glucose Monitoring System. 2016; www.accessdata.fda.gov/cdrh_docs/pdf12/P120005S041b.pdf. Accessed May 31, 2017.
  28. Food and Drug Administration (FDA). News Release:  Freestyle Libre Flash Glucose Monitoring System. 2017; www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm. Accessed January 11, 2018.
  29. Food and Drug Administration. Summary of Safety and Effectiveness Data: Eversense Continuous Glucose Monitoring System(2019). https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048B.pdf. Accessed October November 2, 2020.
  30. Furler J, O'Neal D, Speight J, et al. Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial. Lancet DiabetesEndocrinol. Jan 2020; 8(1): 17-26.
  31. Gandhi GY, Kovalaske M, Kudva Y et al. Efficacy of continuous glucose monitoring in improved glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol 2011; 5(4):952-65.
  32. Garber, AA, Abrahamson, MM, Barzilay, JJ, Blonde, LL, Bloomgarden, ZZ, Bush, MM, Dagogo-Jack, SS, DeFronzo, RR, Einhorn, DD, Fonseca, VV, Garber, JJ, Garvey, WW, Grunberger, GG, Handelsman, YY, Hirsch, II, Jellinger, PP, McGill, JJ, Mechanick, JJ, Rosenblit, PP, Umpierrez, GG. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract, 2019 Feb 12;25(1).
  33. Garg S, Brazg RL, Bailey TS et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery:  the in-clinic ASPORE study. Diab Technol Ther 2012; 14(3):205-9.
  34. Gehlaut RR, Dogbey GY, Schwartz FL, et al. Hypoglycemia in type 2 diabetes--more common than you think: a continuous glucose monitoring study. J Diabetes Sci Technol. Sep 2015; 9(5):999-1005.
  35. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther, 2016 Dec 22;8(1).
  36. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther, 2017 Apr 13;8(3).
  37. Ida, SS, Kaneko, RR, Murata, KK. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. J Diabetes Res, 2019 Feb 19;2019:4684815.
  38. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  39. Klonoff DC, Buckingham B, Christiansen JS et al. Continuous glucose monitoring:  an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2011; 96(10):2968-79.
  40. Kropff, JJ, Choudhary, PP, Neupane, SS, Barnard, KK, Bain, SS, Kapitza, CC, Forst, TT, Link, MM, Dehennis, AA, DeVries, JJ. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial. Diabetes Care, 2016 Nov 7;40(1). 
  41. Laffel LM, Kanapka LG, Beck RW, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents andYoung Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. Jun 16 2020; 323(23): 2388-2396.
  42. Langendam M, Luijf YM, Hooft L et al. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochran Database Syst Rev 2012; 1:CD0081010.
  43. Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: The GOLD randomized clinical trial. Jama. Jan 24 2017; 317(4):379-387.
  44. Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 x 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care. Aug 2014; 37(8):2114-2122.
  45. Ly TT, Nicholas JA, Retterath A, et al. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial. JAMA. Sep 25 2013; 310(12):1240-1247.
  46. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018. Diabetes Care. Jan 2018; 41(Suppl 1):S137-s143.
  47. Mauras N, Beck R, Xing D et al. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years.  Diabetes Care 2012; 35(2):204-210.
  48. National Center for Health and Care Excellence (NICE). Type 1 diabetes in adults: diagnosis and management. www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. Accessed November 2, 2020
  49. National Institute for Health and Care Excellence. Integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). Diagnostics guidance [DG21]. Feb 2016. https://www.nice.org.uk/guidance/dg21/chapter/1-Recommendations. Accessed October 21, 2016.
  50. Pazos-Couselo M, Garcia-Lopez JM, Gonzalez-Rodriguez M, et al. High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study. Can J Diabetes. Oct 2015; 39(5):428-433.
  51. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. Nov 2016; 101(11):3922-3937.
  52. Polonsky WH, Hessler D, Ruedy KJ, et al. The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care. Jun 2017; 40(6):736-741.
  53. Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr 2013; 5(1):39.
  54. Pratley RE, Kanapka LG, Rickels MR, et al. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults WithType 1 Diabetes: A Randomized Clinical Trial. JAMA. Jun 16 2020; 323(23): 2397-2406.
  55. Phillip M, Battelino T, Atlas E et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med 2013; 368(9):824-33.
  56. Riddlesworth T, Price D, Cohen N, et al. Hypoglycemic event frequency and the effect of continuous glucose monitoring in adults with type 1 diabetes using multiple daily insulin injections. Diabetes Ther. Aug 2017;8(4):947-951. 
  57. Sanchez P, Ghosh-Dastidar S, Tweden KS, et al. Real-World Data from the First U.S. Commercial Users of an ImplantableContinuous Glucose Sensor. Diabetes Technol Ther. Dec 2019; 21(12): 677-681.
  58. Sato J, Kanazawa A, Ikeda F, et al. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. Feb 2016; 44(1):109-121.
  59. Secher AL, Ringholm L, Andersen HU et al. The Effect of Real-Time Continuous Glucose Monitoring in Pregnant Women with Diabetes: a randomized controlled trial. Diabetes care 2013 Jul 2013; 36(7):1877-1883.
  60. Sequeira PA, Montoya L, Ruelas V, et al. Continuous glucose monitoring pilot in low-income type 1 diabetes patients. Diabetes Technol Ther. Oct 2013; 15(10):855-858.
  61. Tweden KS, Deiss D, Rastogi R, et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous GlucoseSensor over Multiple Sensor Insertion and Removal Cycles. Diabetes Technol Ther. May 2020; 22(5): 422-427.
  62. Tweden KS, Deiss D, Rastogi R et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor Over Multiple Sensor Insertion and Removal Cycles.. Diabetes Technol. Ther., 2019 Nov 8.
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POLICY HISTORY:

Medical Policy Administration Committee, March 2002

Available for Comment April 15-May 29, 2002

Medical Policy Group, March 2003 (1)

Medical Policy Administration Committee, March 2003

Available for comment April 1-May 16, 2003

Medical Policy Group, March 2004

Medical Policy Administration Committee, April 2004

Available for comment April 6-May 20, 2004

Medical Policy Group, March 2005 (1)

Medical Policy Group, March 2006 (1)

Medical Policy Group, June 2006 (2)

Medical Policy Administration Committee, June 2006

Available for comment July 7-August 21, 2006

Medical Policy Group, January 2007 (3)

Medical Policy Administration Committee, February 2007

Available for comment February 10-March 26, 2007

Medical Policy Group, July 2007 (1)

Medical Policy Group, October 2007 (2)

Medical Policy Administration Committee, October 2007

Available for comment October 20-December 3, 2007

Medical Policy Group, June 2008 (2)

Medical Review Committee, June 2008

Medical Policy Administration Committee, July 2008

Available for comment August 7-September 22, 2008

Medical Policy Group, November 2008 (2)

Medical Policy Administration Committee, December 2008

Medical Policy Group, January 2009 (2)

Medical Policy Group, February 2009 (2)

Medical Policy Panel, March 2010

Medical Policy Group, May 2010(2)

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

Medical Policy Panel, March 2013

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

Medical Policy Administration Committee, June 2013

Available for Comment May 30 through July 13, 2013

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

Medical Policy Administration Committee, April 2014

Available for comment April 4 through May 19, 2014

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

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

Medical Policy Panel, June 2016

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

Medical Policy Panel, November 2016

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

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

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

Medical Policy Panel, July 2017

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

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

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

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

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

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

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

Medical Policy Panel, March 2018

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

Medical Policy Panel, November 2018

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

Medical Policy Panel, July 2019

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

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

Medical Policy Panel, December 2019

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

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

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

Medical Policy Panel, December 2020

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

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

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

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

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

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

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

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

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

3. The technology must improve the net health outcome;

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

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

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

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

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

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

   4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent    

      therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.