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Guidelines / Policy

January 6, 2023
Clinical Outcomes
Guidelines / Policy

The 2023 Standards of Medical Care in Diabetes found Grade A evidence supporting the use of RT-CGM in adults with T1D or T2D on intensive insulin therapy and in adults with T2D on basal insulin. The ADA found Grade B evidence supporting the use of RT-CGM in children and adolescents with T1D on intensive insulin therapy and Grade E evidence for use of RT-CGM in children and adolescents with T2D on intensive insulin therapy. When used as an adjunct to pre- and postprandial BGM, RT-CGM can help to achieve HbA1c targets in pregnant patients with diabetes (Grade B). Based on input from experts, the ADA recommends continued access to RT-CGM through third party payers to people who have been using this technology.

American Diabetes Association. 7. Diabetes Technology: Standards of Care in Diabetes—2023. Diabetes Care. 2022; 46(Suppl 1):S111-S27.

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January 1, 2023
Coverage and Benefit Design
Guidelines / Policy

Effective January 1, 2023, UnitedHealthcare (UHC) is making selected continuous glucose monitoring (CGM) devices and sensors available to Medicare Advantage members at the pharmacy point-of-sale (POS). The systems affected by this change in policy include the Dexcom G6 as well as the FreeStyle Libre 2 and 14-day versions. CGMs were previously only available to UHC Medicare Advantage members through national durable medical equipment (DME) vendors. While availability through DME vendors will remain in place, the plan sought to improve access to CGMs for members by expanding to the pharmacy POS. Managed care decision makers should take note of this change in policy as an example of how national payers are leveraging the pharmacy channel as a means of enhancing coverage and member access to beneficial diabetes technologies.

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November 11, 2022
Clinical Outcomes
Guidelines / Policy

Real-time continuous glucose monitoring (RT-CGM) remains a key technologic advancement recommended for integration into the management of diabetes according to the ADA Standards of Care (SOC) 2022. ADA assigned Grade A evidence to the recommendation that RT-CGM be offered for diabetes management in adults with diabetes on multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII). Similarly, the ADA assigned Grade A evidence to the recommendation that RT- CGM be used for diabetes management in adults with diabetes on basal insulin. ADA’s criteria for a Grade A designation is defined as clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered.

American Diabetes Association Professional Practice Committee, et al. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022;45(Suppl 1):S97-S112.

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November 11, 2022
Clinical Outcomes
Guidelines / Policy

According to the 2022 American Association of Clinical Endocrinology (AACE) Clinical Practice Guideline, CGM is recommended for all persons with T1D, regardless of insulin delivery system, to improve A1C levels and to reduce the risk for hypoglycemia and DKA. The updated guideline likewise recommends CGM for those with T2D who are treated with insulin therapy, or who have high risk for hypoglycemia and/or who have hypoglycemia unawareness. These recommendations are Grade A—indicating the highest strength made by the AACE—and are supported by the best evidence level available, based on data from randomized controlled trials. Managed care and payer professionals should take note of this latest guideline as part of the growing body of consensus recommendations supporting the coverage of CGM in a broader population of members with diabetes.

Blonde L, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. 2022;28(10):923-1049.

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October 7, 2022
Coverage and Benefit Design
Guidelines / Policy

On October 6, 2022, CMS’ DME claims processing contractors released a Proposal to modify Medicare’s CGM coverage policy.

  • CGM coverage is proposed for individuals with diabetes taking as little as one administration of insulin per day (basal only). This differs from the current policy that requires Medicare beneficiaries to use three or more administrations of insulin per day.
  • CGM coverage is proposed for people who are taking no insulin, but have a diabetes diagnosis and who have a history of problematic hypoglycemia with documentation of at least one of the following:
    • Recurrent level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L) that persist despite multiple (2 or more) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or
    • A history of one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia
  • The initial visit to obtain a CGM and visits required every six months thereafter to continue on CGM can be done either in-person, or via telehealth, whereas previously they could only be in-person.
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August 11, 2022
Coverage and Benefit Design
Guidelines / Policy

The National Committee for Quality Assurance (NCQA) is revising its Healthcare Effectiveness Data and Information Set (HEDIS) standardized measures assessing plan performance for 2023. Notably, the 2023 dataset will include a new measure related to diabetes management: the risk-adjusted ratio of observed to expected emergency department visits for hypoglycemia among older adults (aged ≥67 years) with diabetes.

This measure reflects a key component of health plan quality pertaining to the management of diabetes, since older adults are more likely to experience severe hypoglycemia, potentially leading to several adverse outcomes: fall-related events and fractures, increased risk of cardiovascular events, and cognitive decline. Similarly, prevailing clinical practice guidelines for the treatment of older adults with diabetes emphasize the prevention of hypoglycemia as an important outcome. The new HEDIS measure provides an opportunity for health plans to identify older members with diabetes who are at highest risk of hypoglycemia and implement preventive interventions and more intensive management.

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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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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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