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Featured Resource
Leveraging Diabetes Health Technology in Managed Care and Coverage Considerations for Real-Time Continuous Glucose Monitoring
Announcing a new white paper based on key findings from the Therapeutic CGM Health Care Stakeholder Summit held on November 7, 2019, in Washington, DC. The stakeholder panel included payer and employer leadership along with clinical experts in the field of endocrinology. The purpose was to gather input pertinent to the coverage and application of therapeutic continuous glucose monitoring (CGM) in managed care settings. Clinical evidence supporting the clinical and economic value of rtCGM was presented and the insights of these health care stakeholders were captured en route to formulating coverage policy recommendations for the future. This input is intended to advance the uptake and appropriate coverage of evidence-based health technology interventions by managed care organizations (MCOs) and various payers.
Click here to download the white paper.
Click here to download the white paper in black and white.
Review Articles
Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring
Source: Diabetes Care
Key Takeaways: CGM has emerged as a new standard of care for individuals with insulin-treated diabetes. Two types of CGM systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data in real time to a smart phone and/or other display device. The current isCGM system provides the same type of data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.
Continuous Glucose Monitoring: An Emerging Standard of Care
Source: American Journal of Managed Care
Key Takeaway: The use of CGM is proven to reduce A1C, reduce time spent in hypo- and hyperglycemia and improve time in range (TIR) for Type 1 and Type 2 patients using intensive insulin, defined as multiple daily injections of insulin or getting insulin through an insulin pump. This has resulted in guidelines and recommendations from professional societies such as the ADA recommending CGM as a standard of care for Type 1 and Type 2 patients using intensive insulin. CGM is an important monitoring tool that is best accessed by providers and patients in the pharmacy channel.
Continuous Glucose Monitoring with Dexcom G6
Source: First Report Managed Care
Key Takeaway: Diabetes is a complex chronic disease that for some Type 1 and Type 2 patients requires the use of intensive insulin defined as 3 or more injections/day or insulin through a pump. The adverse consequences of using insulin are severe and can result in a coma, seizure or even death which leads many patients and caregivers deciding to use less insulin as prescribed preventing achievement of glycemic goals. Real-time CGM with alerts/alarms, remote monitoring and reporting can help patients use their insulin safely and effectively to achieve lower A1Cs, spend less time in hypo- and hyperglycemia and spend more time in range (TIR). The benefits of CGM are seen when it is used to make diabetes treatment decisions such as insulin dosing, diet and lifestyle in a timely manner. Accessing CGM devices via a pharmacy benefit allows patients to start CGM faster, stay safe while using insulin and engage pharmacists, providing additional support and interventions that have been shown to improve diabetes outcomes.
Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range
Source: Diabetes Care
Key Takeaway: Successful utilization of CGM technology in routine clinical practice remains relatively low due to a lack of clear and agreed-upon glycemic targets that both diabetes teams and people with diabetes can work toward. In February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address this issue and established targets for time in range (TIR), time below range (TBR) and time above range (TAR). These are metrics that only CGM can measure and overcome the limitations of metrics such as A1C which are reflective of a 3 month average of glycosylated hemoglobin and does not account for day to day glycemic variability or factors such as anemia which can skew A1C low.
CGM-based Targets for Different Diabetes Populations
Real-World Evidence
Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes
Source: Diabetes Technology & Therapeutics
Key Takeaway: CGM initiated within the first year of T1D diagnosis was effective in lowering and maintaining A1C for 2.5 years and reduced the frequency of ED visits related to hypoglycemia and hyperglycemia irrespective of insulin delivery method.
Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study
Source: The Journal of Clinical Endocrinology & Metabolism
Key Takeaway: Nationwide reimbursement of real-time CGM improved HbA1c, fear of hypoglycemia, and QOL as well as economic indicators including work absenteeism and hospital admissions for acute diabetes complications.
One-Year Time Analysis in an Academic Diabetes Clinic: Quantifying Our Burden
Source: Endocrine Practice
Key Takeaway: In an academic diabetes clinic, between-visit nonbillable time by nonphysicians is significant, costly, and most importantly, not sustainable. We clearly require a less burdensome mechanism to carry out evidence-based decisions for a condition that is a public health crisis.
Clinical Studies
Real Time CGM Studies
Effect of Continuous Glucose Monitoring on Glycemic Control in Adults with Type 1 Diabetes Using Insulin Injections – The DIAMOND Randomized Clinical Trial
Source: Journal of the American Medical Association
Key Takeaway: In the DIAMOND RCT, patients using multiple daily injections of insulin with type 1 diabetes who were randomly assigned to real-time CGM (rtCGM) had improved glycemic control vs. the SMBG group. This benefit was seen across patient groups regardless of baseline A1C, age, education level, or math ability. In addition, the rtCGM group spent 79% less time in nocturnal hypoglycemia, and also demonstrated a greater increase in hypoglycemic confidence and a greater decrease in diabetes distress vs. the SMBG group.
Baseline Glycated Hemoglobin Values Predict the Magnitude of Glycemic Improvement in Patients with Type 1 and Type 2 Diabetes: Subgroup Analyses from the DIAMOND Study Program
Source: Diabetes Technology & Therapeutics
Key Takeaway: Among the real-time CGM (rtCGM) users, the change in HbA1c was greatest in the highest HbA1c subgroup with similar decreases seen in both the T1D and T2D groups. Notably, adherence remained high in those with baseline HbA1c > 9% and the improvements seen were achieved without the need for additional medications. Thus, the costs of rtCGM in patients with high HbA1c may be offset by avoiding treatment intensification and the longer-term savings achieved by lowering HbA1c levels in poorly controlled diabetes populations.
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
Source: Journal of the American Medical Association
Key Takeaway: In the GOLD trial, glycemic control was improved with use of rtCGM compared with conventional treatment; however, increases in A1C and hypoglycemic events occurred when patients reverted back to SMBG during the crossover/washout period, suggesting that the effectiveness of CGM depends on uninterrupted use during treatment with MDI. Additionally, the study showed reductions in severe and nocturnal hypoglycemia as well as in glycemic variability and improved hypoglycemic confidence for rtCGM users.
Glycemic Outcomes in Adults With T1D Are Impacted More by Continuous Glucose Monitoring Than by Insulin Delivery Method: 3 Years of Follow-Up From the COMISAIR Study
Source: Diabetes Care
Key Takeaway: The COMISAIR study is the longest running real-world real-time CGM (rtCGM) study performed to date. In this study, the continuous use of rtCGM had a sustained and durable benefit with regards to glycemic control over a 3-year time period, with rtCGM being superior to self-monitoring of blood glucose in reducing A1C, hypoglycemia, and glycemic variability in individuals with type 1 diabetes regardless of their insulin delivery method.
Observational COMISAIR Study in Patients With T1D Who Chose Insulin Delivery Method (MDI or Pump) and Monitoring Method (SMBG or CGM), Staying on Chosen Therapy for 3 Years
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Source: The New England Journal of Medicine
Key Takeaway: This 6 month randomized trial showed use of a closed-loop system using the t:slim X2 insulin pump with Control-IQ Technology, (Tandem Diabetes Care) and a continuous glucose monitor (Dexcom G6, Dexcom) was safe and effective compared to sensor-augmented pump therapy (SAP). Participants in the closed-loop group achieved 70% time in range overall which meets the International Consensus Guidelines for people with diabetes. The closed-loop group also achieved significant improvements in hyperglycemia, HbA1c, mean glucose, and hypoglycemia (< 70 mg/dL < 54 mg/dL) as compared with the SAP group. Glycemic benefits were seen in the first month of the trial and were sustained over the entire 6-month period. Over 90% of participants said they trusted the device and found Control-IQ technology easy to use.
*Full article available for a fee
Intermittently Scanned CGM
Novel Glucose-sensing Technology and Hypoglycaemia in Type 1 Diabetes: A Multicentre, Non-masked, Randomised Controlled Trial
Source: The Lancet
Key Takeaway: This study conducted in Europe with over 300 participants found novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups.
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
Source: Diabetes Therapy
Key Takeaway: Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.
Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living with Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study
Source: Diabetes Care
Key Takeaway: Nationwide unrestricted reimbursement of isCGM in people with type 1 diabetes treated in specialist diabetes centers results in higher treatment satisfaction, less severe hypoglycemia, and less work absenteeism, while maintaining quality of life and HbA1c.
A1C From Baseline to 12 Months After Initiation of isCGM
Professional Guidelines
Diabetes Technology: Standards of Medical Care in Diabetes – 2020
Source: Diabetes Care
Key Takeaway: The ADA Standards of Medical Care in Diabetes provides the most authoritative and current guidelines for diabetes care. The recommendations are intended to provide clinicians, patients, researchers and payers with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care. Following are ADA recommendations regarding CGM:
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rtCGM should be used continuously for maximal benefit. isCGM should be scanned frequently throughout the day (minimum of once every 8 hours) |
CGM and T1D
CGM and T2D
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Level of Clinical Evidence: A = Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered; B = Supportive evidence from well-conducted cohort studies; C = Supportive evidence from poorly controlled or uncontrolled studies
Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinologists and American College of Endocrinology
Source: American Association of Clinical Endocrinologists
Conclusion: CGM improves glycemic control, reduces hypoglycemia, and may reduce overall costs of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes.
Health Economics and Outcomes Research (HEOR)
Advancing Glycemic Management in People with Diabetes
Source: The IQIVA Institute
About the report: The incorporation of time in range (TIR) metrics alongside HbA1c is expected to enhance the way in which diabetes is managed in the future, and subsequently, reduce the overall societal and economic burden. To assess the value of improving TIR from its current state to the minimum consensus target of 70% and 80% TIR, the IQVIA Core Diabetes Model was used to estimate cost reductions in complications and costs associated with improving TIR. Using this model, improvements in TIR were estimated to reduce the risk of developing diabetes-related complications resulting in a conservative reduction of $2.1-7 billion in costs over a 10-year period, based on the relationship between TIR and HbA1c. The addition of incrementally reducing hypoglycemic events in people with Type 1 Diabetes by 40% and improving TIR to 80% generated a total 10-year cost reduction of $6.7-9.7 billion. This reduction in costs represents a conservative estimate.
10-Year Cost Reduction by Improving TIR in People with T1 and T2 Diabetes to 70% and 80% TIR (US$Bn)
Free On-demand Webinar: A Movement in Diabetes: Using Time-in-Range
Source: Applied Clinical Trials
Key Takeaway: This webinar presents the first estimation of reduction in complications and costs associated with improving time-in-range per research found in the Advancing Glycemic Management in People with Diabetes report. You will hear directly from an advocate for people with diabetes about the Time-in-Range movement and gain an understanding about what’s to come in the realm of diabetes care management.
Cost Offset Analysis (COA) Comparing Real-Time Continuous Glucose Monitoring (RT-CGM) With Self-Monitoring of Blood Glucose (SMBG) in People With Type 1 Diabetes in Eight Countries
Source: Advanced Technologies & Treatments in Diabetes
Key Takeaway: A cost offset analysis (COA) was performed comparing potential clinical cost offsets for reduced HbA1c, severe hypoglycemia, and diabetic ketoacidosis using a rt-CGM system compared with SMBG alone in people with Type 1 Diabetes (T1D) and uncontrolled glycemia, in eight countries (n=5,000 per country), over a one-year time period. This modelling study demonstrates significant potential clinical and economic benefits for rt-CGM compared with SMBG in people with T1D.
Coverage and Benefit Design
Recent News
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Effective April 1, 2020, Blue KC will also offer coverage for Continuous Glucose Monitors (CGMs) as a pharmacy benefit. While members can continue to utilize their DME benefits instead of pharmacy benefits for CGMs, some brands may eventually no longer be available through DME suppliers. Additionally, the process of obtaining a CGM through the pharmacy is likely a more timely, convenient, and overall better member experience.
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Effective April 20, 2020 Aetna considers the long-term (greater than 1 week) therapeutic use of continuous glucose monitoring devices medically necessary in adults aged 18 years and older with type 1 diabetes, adults with type 2 diabetes using intensive insulin regimens (multiple (3 or more) daily injections or insulin pump therapy) who are not meeting glycemic targets, and for younger persons with type 1 diabetes.
- Effective April 1st 2020 United Health Care covers long-term CGM for individuals with type 1 or type 2 diabetes when certain criteria are met.
- Effective April 1, 2020, therapeutic continuous glucose monitors (CGMs) will be a benefit of Texas Medicaid for individuals with type 1 or type 2 diabetes who meet medical criteria.
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Missouri Medicaid’s Pharmacy Program will begin covering the Dexcom G6 Continuous Glucose Monitoring (CGM) System as the preferred CGM system effective April 2, 2020.
CMS-1682R – Therapeutic CGM Category
Source: Centers for Medicare & Medicaid Services
Key Takeaway: Recognizing the value of CGM, and in response to the recent FDA approvals of CGM as a replacement for fingersticks, CMS created a benefit category for therapeutic CGMs, providing for coverage of these devices under the following conditions:
- The beneficiary has diabetes mellitus (Refer to the “ICD-10 Codes that are Covered” section of the LCD-related Policy Article for applicable diagnoses); and,
- The beneficiary has been using a BGM and performing frequent (four or more times a day) testing; and,
- The beneficiary is insulin-treated with multiple (three or more) daily injections of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump; and,
- The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
- Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
- Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.
Current Eligibility Requirements for CGM Coverage Are Harmful, Costly, and Unjustified
Source: Diabetes Technology and Therapeutics
Key Takeaway: There is growing and compelling evidence that CGM coverage should be offered to all patients who can benefit from this technology regardless of diabetes type and history of SMBG use. The current restrictions, which are based on outdated evidence and questionable assessments, are not supported in the literature. Moreover, they ignore the burden frequent SMBG places on individuals. Given the growing prevalence of diabetes, the persistent preponderance of individuals with suboptimal glycemic control, and the exorbitant and largely preventable cost of diabetes complications, opinion-based constraints should not continue to supplant evidence-based clinical management.
Medicaid Coverage
*Map updated April 1, 2020
Medicaid Policies
- Illinois Department of HealthCare and Human Services Pharmacy
- Washington State Health Care Authority
- Vermont Medicaid Pharmacy; Vermont Medicaid Medical
Commercial Coverage
National
Regional
Non-CE Education Resources
The Clinical and Economic Value of Continuous Glucose Monitoring and Improved Time in Range
Source: AMCP Science and Innovation Theater Webinar
Improving Outcomes in Intensively Treated Type 1 and Type 2 Diabetes with Continuous Glucose Monitoring
Source: AMCP Science and Innovation Theater Webinar
AMCP Formulary Dossiers
Commercial and Medicaid Formulary Dossiers for Dexcom G6 Continuous Glucose Monitoring Systems Available
Source: FormularyDecisions.comSM
Other Resources
The New Standard of Care: Continuous Glucose Monitoring in Pharmacy Practice
Source: RxInsider
Free On-demand Archive:
Continuous Glucose Monitoring: Complete Care Management Solution for Diabetes
Intended Audience: Case Managers – During the CCMC New World Symposium that took place from February 28, 2019, to March 2, 2019, Nicholas B. Argento, MD, FACE, Diabetes Technology Director of Maryland Endocrine in Columbia, Maryland, presented a satellite breakfast symposium on continuous glucose monitoring (CGM) that was sponsored by Dexcom.
Click here to read about this presentation in CareManagement.
Leading CGM Innovation with Dexcom G6® – The Only Fully Interoperable, Zero Fingerstick CGM System – A Science & Innovation Theater held in conjunction with the Academy of Managed Care Pharmacy’s Annual Meeting 2019
Source: AMCP Science and Innovation Theater Webinar
Description: Dexcom G6® is the first CGM to receive the integrated CGM classification by the FDA. Dexcom G6® is approved for use as a standalone CGM and for integration with bluetooth connected insulin pens and automated insulin delivery systems. This presentation will highlight Dexcom’s technology, connected ecosystem, Google/Verily partnership, and future developments including EHR integration, population-level insights, and decision support algorithms.
Product Comparison for Self-Inserted Therapeutic CGM Systems
| Product Attributes and Performance | G6® CGM System (Dexcom)1 | FreeStyle® Libre Flash Glucose Monitoring System (Abbott)2 |
| CGM Classification | Real-Time CGM | Intermittent Scan CGM |
| Continuous data availability | Data available without user intervention | Data available only with user intervention (i.e. user must scan sensor) |
| Age indication (years) | 2+ | 18+ |
| Confirmatory fingerstick required per labeled indications: | ||
| – When experiencing symptoms that do not match sensor glucose readings | Yes | Yes |
| – When experiencing symptoms that may be due to low or high blood glucose | No | Yes |
| – During times of rapidly changing glucose (i.e., trend arrows↑↓) | No | Yes |
| – To confirm hypoglycemia or impending hypoglycemia as reported by the sensor | No | Yes |
| – Anytime the check BG icon appears | No | Yes |
| – During first 12 hours of sensor wear | No | Yes |
| Meets integrated CGM Class Criteria | Yes | No |
| FDA Classification/Pathway Relative Risk Designation | Class II DeNovo6 Medium Risk | Class III PMA7 High Risk |
| Meets Medicare therapeutic CGM criteria | Yes | Yes |
| Factory-calibrated | Yes (manual calibration optional) | Yes |
| Ease of use/sensor insertion | No assembly required; 4 steps | No assembly required; 3 steps |
| Sensor wear | 10 days | 14 days |
| Sensor life, adults >18 (% sensors working at end of maximum indicated use) | 94% @ 10 days | 71.6% @ 14 days |
| Sensor warm-up time | 2 h | 1 h |
| FDA approved sensor sites | Abdomen (adults) Abdomen, upper buttocks (pediatrics) | Upper arm |
| Protective Safeguards (alerts/alarms): – Predictive hypoglycemia alert | Yes | No |
| – Provides updates without user interaction (i.e. during sleep) | Yes | No |
| – Real-time, customizable glucose alerts (low/high) | Yes | No |
| – Rapidly rising/falling rate of change alerts | Yes | No |
| – Urgent low glucose safety alarm | Yes | No |
| Moisture protection | Water resistant up to 8 feet for 24 h | Water resistant up to 3 feet for 30 min |
| Insulin pump integration | Yes; Tandem t:slim X2™ | Yes; not commercially available |
| Smart insulin pen integration | Yes; Companion InPen™ | Yes; not commercially available |
| Communication range | 20 feet | 1.5 in |
| Mobile device connectivity | Yes; iOS and Android via bluetooth | Yes; iOS and Android can be used to scan sensor for data via near field communication |
| Remote monitoring | Yes; continuous | Yes; upon scanning3 |
| Known interfering substances | Hydroxyurea | Ascorbic Acid at doses >500 mg may cause falsely higher readings; Salicylic Acid at doses >650 mg may cause falsely lower glucose values4 |
| FDA Warning for Use in Hypoglycemia Unawareness Patients | No | Yes |
| Data storage | Data automatically stored without user intervention | Data stored when user scans the sensor. Sensor must be scanned at least once every 8 hours to prevent data loss |
| EHR Integration Capability | Yes – Epic, Cerner (limited availability) | N/A |
| Overall accuracy MARD (average % discrepancy between CGM and reference YSI, 40-400 mg/dL) | 9.0% (overall); 9.8% (adults); 7.7% (children) | 10.1% (SSED data) |
| Hypoglycemia accuracy (Concurrence of sensor readings with YSI-measured values in the critically low range 40-60 mg/dL) | 63% | 25% |
| Accuracy during rapid rates of change (Concurrence of sensor readings with YSI- measured rates of change) | ||
| Rapidly Falling: > 2 mg/dL/min | 53.3% | 37.7% |
| Rapidly Rising: > 2 mg/dL/min | 71.3% | 40.4% |
References:
1Dexcom G6 CGM System User Guide 2018; 2Abbott FreeStyle Libre 14 day System User Guide 2018; Summary of Safety and Effectiveness Data (SSED), Abbott FreeStyle Libre, July 2018; 3Sharing function is not real-time (glucose information can only be viewed by the follower after the user scans their sensor with their smart device) https://www.librelinkup.com/; 4Approach to Using Trend Arrows in the FreeStyle Libre Flash Glucose Monitoring Systems in Adults. Endocrine Society 2018; 5ADA Standards of Medical Care in Diabetes- 2020. 6FDA authorizes first Class II Interoperable CGM system. 7Class III PMA Approval for Abbott Freestyle Libre Flash Glucose Monitoring System
