Guidelines / Policy
The Centers for Medicare and Medicaid Services (CMS) expanded CGM access to beneficiaries on basal-only insulin or those with a history of level two or three hypoglycemia. Although the Local Coverage Determination (LCD) was originally anticipated to be implemented in July, CMS expanded access to CGM on April 16, 2023. This new coverage policy is aligned with consensus guidelines from the ADA and AACE, which recommend CGM for all patients on insulin at the outset of diagnosis. The new LCD, which was proposed in 2022, also removes the term “daily” as a descriptor for insulin to account for potential FDA approval of weekly insulins in the future.
Learn MoreThe 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 American Diabetes Association (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.
Learn MoreEffective 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.
Learn MoreReal-time continuous glucose monitoring (RT-CGM) remains a key technologic advancement recommended for integration into the management of diabetes according to the American Diabetes Association (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.
Learn MoreAccording 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.
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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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:
| Criterion | Supporting Evidence |
| 1. Diagnosed with T1D. | CGM use confers: Significant reductions in • HbA1c • severe hypoglycemia events • %TBR • diabetes-related hospitalizations Significant improvements in |
| 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 hypoglycemia | CGM 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 Use of downloaded CGM data into standardized reports: |
Click here to view CGM Payer Insights Sheet with key findings.
Learn MoreAmerican 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: |
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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
Learn MoreSource: 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
| 1.3.17 | Offer 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. |
| 1.3.18 | Offer 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. |
| 1.3.19 | Consider 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. |
| 1.3.20 | For 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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