June 2, 2021
Coverage and Benefit Design
Guidelines / Policy

Source: Diabetes Technology & Therapeutics

Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion: 

CriterionSupporting Evidence
1. Diagnosed with T1D.CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations

Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress

2. Diagnosed with T2D and treated with any insulin regimen.CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR
3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemiaCGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and

Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence

4. Advanced CKD at risk for hypoglycemia.CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis
5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.)Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress

Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method

Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management

Click here to view CGM Payer Insights Sheet with key findings.

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June 2, 2021
CGM Technology and Digital Health
Guidelines / Policy

American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus

Source:

The American Association of Clinical Endocrinology (AACE) with a task force of medical experts developed evidence-based guideline recommendations regarding the use of advanced diabetes technology in clinical settings. The guidelines reveal that ensuring universal access to advanced diabetes technologies is anticipated to result in improved glycemia and allowing more persons with diabetes to achieve glycemic targets, improve quality of life, and potentially reduce burden of care. Furthermore, diabetes technology can improve the efficiency and effectiveness of clinical decision-making.

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  • CGM is strongly recommended for all persons with diabetes treated with intensive insulin therapy, defined as 3 or more injections of insulin per day or an insulin pump1
  • CGM is recommended for:
    • All individuals with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness).2
    • Children/adolescents with T1D.2
    • Pregnant women with T1D and T2D treated with intensive insulin therapy.2
    • Women with gestational diabetes mellitus (GDM) on insulin therapy.3
  • CGM may be recommended for:
    • Women with GDM who are not on insulin therapy.3
    • Individuals with T2D who are treated with less intensive insulin therapy.4
Real-time CGM should be recommended over intermittently scanned CGM for:isCGM should be considered for:
  • persons with diabetes with problematic hypoglycemia (frequent/severe hypoglycemia, nocturnal hypoglycemia, hypoglycemia unawareness) who require predictive alarms/alerts; however the lifestyle of persons with diabetes and other factors should also be considered5
  • persons with diabetes who meet 1 or more of the following criteria6
    • Newly diagnosed with T2D
    • Treated with nonhypoglycemic therapies
    • Motivated to scan device several times per day
    • At low risk for hypoglycemia, but desire more data than SMBG provides

1Grade A; High Strength of Evidence; BEL 1; 2Grade A; Intermediate-High Strength of Evidence; BEL 1; 3Grade A; Intermediate Strength of Evidence; BEL 1; 4Grade B; Intermediate Strength of Evidence, BEL 1; 5Grade B; Low-Intermediate Strength of evidence; BEL; 6Grade D; Low Strength of Evidence/Expert Opinion of Task Force; BEL 

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May 18, 2021
Coverage and Benefit Design
Economic Outcomes
Conference Updates

Source: Improving Quality Metrics and Reducing Cost of Care with Access to Real-Time Continuous Glucose Monitoringa symposium at the Academy of Managed Care Pharmacy 2021 Virtual Annual Meeting.

Featuring expert faculty:

Jeffrey Dunn, PharmD, MBA
Head of Clinical Pharmacy
Berkshire Hathaway/Geico
(Formerly) Vice President, Clinical Strategy and Programs and Industry Relations
Magellan Rx Management

Maria Lopes, MD, MS
Former Chief Medical Officer
Magellan Health
Former Practicing Obstetrician and Gynecologist

Janet B. McGill, MD, MA, FACE, FACP
Professor of Medicine
Washington University School of Medicine
Vanita Pindolia, PharmD, BCPS, MBA
Vice President, Ambulatory Clinical Pharmacy Programs_PCM
Henry Ford Health System/Health Alliance Plan of Michigan

Key Takeaways: 

  • All insulin treated members,  particularly high-risk older adults, should have streamlined access to real-time CGM, and payers should reconsider coverage criteria, such as removing intensive insulin eligibility criteria for T2D and streamlining the documentation requirements.
  • Pharmacy coverage and access for appropriate subpopulations can confer immediate cost savings.
  • Consensus guidelines recommend the use of rtCGM in pregnant women with pre-existing T1 and T2D and GDM. A delay in access to CGM can have adverse consequences in terms of both maternal and neonatal outcomes.
  • rtCGM allows for a new frontier of diabetes management through remote monitoring and innovative patient engagement in telemedicine initiatives.

Jointly provided by Impact Education, LLC, and Medical Education Resources.
This activity is supported by an independent educational grant from Dexcom, Inc.

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May 10, 2021
Clinical Outcomes
Article / Publication

Source: Diabetes Technology and Therapeutics

Key Takeaway: The CONCEPTT (CGM in pregnant women with type 1 diabetes) trial provided high-quality, randomized-controlled trial data demonstrating that the use of real-time CGM was associated with lower HbA1c at 34 weeks, suggesting improved maternal glucose levels during the late second and early third trimesters. Importantly, this was accompanied by 7% higher time in range (TIR) and 5% lower time above range (TAR) without increasing maternal hypoglycemia. Beyond impacting surrogate markers of maternal glycemia, using CGM led to clinically significant reductions in large for gestational-age infants, neonatal hypoglycemia, and neonatal intensive care unit (NICU) admissions.1 A systematic review combining data from CONCEPTT with that of the type 1 diabetes arm of the GlucoMOMS trial also showed evidence for a reduction in preeclampsia.

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March 29, 2021
CGM Technology and Digital Health
Webinar / Archive

Watch the APhA 2021 Annual Meeting and Exposition Presentation Theatre on the power of real-time continuous glucose monitoring, featuring:

Dr. Diana Isaacs
Endocrine Clinical Pharmacist & Remote Monitoring Program Coordinator
Cleveland Clinic

Dr. Jessica Haskins
Community Walgreens Site Manager
Austin, TX

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March 1, 2021
Clinical Outcomes
Article / Publication

Source: Diabetes Technology and Therapeutics

Key Takeaway: The Landmark study demonstrated significant glycemic and QoL benefits for first time CGM use among individuals using intensive insulin therapy to manage either T1D or T2D. After approximately 12 weeks of Dexcom G6 use, participants had a mean absolute reduction in HbA1c levels of 1.1%, and more than half of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. The reduction in HbA1c observed in Landmark was similar for patients with T1D and T2D and was more pronounced for participants with higher baseline HbA1c, consistent with observations from the DIAMOND randomized controlled trial. Significant reductions in diabetes distress and hypoglycemic concerns were also observed. In the Landmark study, there was no standardized training or intervention at CGM initiation, suggesting that the glycemic benefits can be realized without formal instruction.

Changes in HbA1c according to baseline HbA1c level

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February 26, 2021
CGM Technology and Digital Health
Article / Publication

Source: Association of Diabetes Care & Education Specialists and American Pharmacists Association

Key Takeaway: Developed by the Association for Diabetes Care and Education Specialists in partnership with APhA, this newly created Personal Continuous Glucose Monitoring (CGM) Implementation Playbook will help you implement a personal CGM program within your pharmacy practice.

This guide brings together fragmented information available from multiple sources to provide an inclusive and unbiased approach to implementation of Personal CGM into your practice, whatever its size. It includes a step-by-step approach to implementation, additional resources, and the latest research.

Download this free guide and start the process of incorporating this potentially game-changing tool for your patients living with diabetes.

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February 26, 2021
CGM Technology and Digital Health
Article / Publication

Source: Association of Diabetes Care & Education Specialists and American Association of Nurse Practitioners 

Key Takeaway: This toolkit provided by ADCES and AANP will help you implement a professional CGM program within your health system. Implementing a program within a healthcare setting offers many advantages, including: promotion of self-motivated, data-driven behavior change and improved clinical outcomes through alignment of medication with behavior change, resulting in lowered long-term healthcare costs for people with type 1 and type 2 diabetes.

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February 10, 2021
CGM Technology and Digital Health
Article / Publication

Source: Diabetes Technology & Therapeutics

Key Takeaway:  The role of real-time continuous glucose monitoring (rtCGM) is an essential component of telemedicine visits for people with diabetes. This observational study demonstrated that people with type 2 diabetes (T2D) participating in a virtual diabetes clinic can successfully insert and use Dexcom rtCGM without in-office training. The use of rtCGM was associated with a significant improvement in HbA1c at 10 months in those not meeting the ADA treatment target, independent of insulin use. In addition, there was a large shift in the percentage of participants meeting the HEDIS HbA1c target of <8.0% at follow-up; this may have important clinical and economic implications.

Chart: Percentage of Participants Achieving HEDIS HbA1c Treatment Target (HbA1c <8.0%) Before and After rtCGM Use

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January 29, 2021
Clinical Outcomes
Guidelines / Policy

Source: National Institute for Health and Care Excellence (NICE) Guideline – Diabetes in Pregnancy: Management from Preconception to the Postnatal Period (2020)

Key Takeaway: In December 2020, NICE reviewed the evidence and changed the recommendations on intermittently scanned CGM (isCGM, also commonly referred to as flash) and continuous glucose monitoring during pregnancy for women with type 1 diabetes.

Recommendations for Managing Diabetes During Pregnancy-Intermittently scanned CGM and continuous glucose monitoring

1.3.17Offer continuous glucose monitoring (CGM) to all pregnant women with type 1 diabetes to help them meet their pregnancy blood glucose targets and improve neonatal outcomes. 
1.3.18Offer intermittently scanned CGM (isCGM, commonly referred to as flash) to pregnant women with type 1 diabetes who are unable to use continuous glucose monitoring or express a clear preference for it. 
1.3.19Consider continuous glucose monitoring for pregnant women who are on insulin therapy but do not have type 1 diabetes, if they have problematic severe hypoglycaemia (with or without impaired awareness of hypoglycaemia) or they have unstable blood glucose levels that are causing concern despite efforts to optimise glycaemic control.
1.3.20For pregnant women who are using isCGM or continuous glucose monitoring, a member of the joint diabetes and antenatal care team with expertise in these systems should provide education and support (including advising women about sources of out-of-hours support).

For a short explanation of why the committee made the 2020 recommendations and how they might affect practice, see the rationale and impact section on flash and continuous glucose monitoring on pages 35-36 in the Guideline. Full details of the evidence and the committee’s discussion are in evidence review A: continuous glucose monitoring.

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