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:
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.
LEARN MORESource: Centers for Medicare & Medicaid Services
Key Takeaway: CMS expanded Medicare coverage for therapeutic CGMs. Most notably, eliminating a requirement that beneficiaries use four fingerstick tests per day prior to accessing CGM. According to the local coverage determination, “there is no evidence to support that frequent SMBG (≥4 times per day) as a prerequisite for initiating CGM use is predictive of improved health outcomes”.
New Coverage Criteria (Effective July 18, 2021)
The revised LCD indicates that Medicare coverage for CGMs will be available if the beneficiary meets the following criteria:
- The beneficiary has diabetes mellitus; and,
- The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a 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 (1-3) 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.