What's Wrong with This Picture? A Critical Review of Current Centers for Medicare &amp; Medicaid Services Coverage Criteria for Continuous Glucose Monitoring

Galindo, Rodolfo J.; Parkin, Christopher G.; Carlson, Anders; Kruger, Davida F.; Levy, Carol J.; Umpiérrez, Guillermo E.; McGill, Janet B.

doi:10.1089/dia.2021.0107

Cited by 28 publications

(17 citation statements)

References 76 publications

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“…It is time to revise the Medicare criteria for CGM to reflect the current scientific evidence and simultaneously mitigate disparities in CGM access and diabetes control. 13,15 Fourth, the RCT results suggest that patient engagement (ie, improved insulin adherence, changes in diet, or increased physical activity in response to CGM readings) was the most likely source of improved glycemic control because there were no differences in the total amount of insulin between study groups or in the amount of medication adjustments by clinicians. Activated patients are a powerful part of achieving diabetes control.…”

Section: Related Articlesmentioning

confidence: 99%

Broadening Access to Continuous Glucose Monitoring for Patients With Type 2 Diabetes

Peek

Thomas

2021

JAMA

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Persons from racial and ethnic minority populations, those in low-income groups, and other socially marginalized groups are disproportionately affected by type 2 diabetes and experience higher disease prevalence, poorer glycemic control, higher rates of diabetes complications, and higher prevalence of comorbid conditions. 1,2 Achieving glucose targets that will reduce the risk of diabetes complications, particularly among high-risk groups, is critical to improve the health and well-being of those with diabetes and to reduce health care utilization and expenditures. Yet, diabetes control remains elusive. Self-monitoring of blood glucose, while still a standard part of diabetes self-management, has not been shown to result in self-adjustments to insulin in primary care settings. This represents a significant opportunity gap because 30% of patients with type 2 diabetes are treated with some form of insulin. 3 Real-time continuous glucose monitoring (CGM), which measures glucose levels in subcutaneous interstitial fluid as frequently as every 5 minutes, has been shown to improve diabetes control, reduce hypoglycemia, and be cost-effective for patients with type 1 diabetes. 4,5 Less research has been conducted among patients with type 2 diabetes, but clinical trials involving patients using intensive insulin regimens (eg, basal/ bolus insulin) have shown reductions in hemoglobin A 1c (HbA 1c ) levels and shorter intervals of hypoglycemia. 6,7 Several questions remain: Can the results of clinical trials of patients with type 2 diabetes be translated into usual care settings? Can patients with type 2 diabetes who use less intensive insulin regimens benefit from CGM? Can CGM be feasibly implemented in primary care settings, where most of type 2 diabetes management occurs? In this issue of JAMA, the randomized clinical trial (RCT) reported by Martens et al 8 and the observational study reported by Karter et al 9 provide new data that help provide answers to these questions.Martens et al 8 conducted an RCT of CGM (n = 116) vs blood glucose meter (BGM) monitoring (n = 59) among adults with type 2 diabetes who were taking basal insulin without prandial insulin and were recruited from primary care practices. At 8 months, the mean HbA 1c level improved from 9.1% to 8.0% in the CGM group and from 9.0% to 8.4% in the control group (adjusted difference, −0.4% [95% CI, −0.8% to −0.1%]). This effect size may have been greater if the control group had received usual care rather than instructions on how to self-titrate insulin based on BGM data. Compared with the BGM group, the time in range, or the amount of time spent in the target blood glucose range (70-180 mg/dL), was 3.6 hours per day higher, the mean glucose level was

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Section: Related Articlesmentioning

confidence: 99%

Broadening Access to Continuous Glucose Monitoring for Patients With Type 2 Diabetes

Peek

Thomas

2021

JAMA

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“…A recent pair of publications examined the Centers for Medicare and Medicaid Services coverage criteria for insulin pumps and CGMs. 122 , 123 These commentaries call for coverage criteria based on modern device use profiles and evidence-based requirements. They also note the demonstrated cost effectiveness of CGM and CSII technologies.…”

Section: Expert Opinion On Potential Solutionsmentioning

confidence: 99%

Barriers to Uptake of Insulin Technologies and Novel Solutions

PAULEY¹,

Berget²,

Messer³

et al. 2021

MDER

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“…Patient-reported outcomes indicate that use of these devices leads to a better understanding of and control of glucose levels and reduced fear of hypoglycemia. Additionally, use of these devices may be associated with reduced burden of diabetes-related care, diabetes distress, and acute diabetes complications (12)(13)(14). Nonetheless, newer diabetes devices are underutilized.…”

Section: Virtual Carementioning

confidence: 99%

“…The CMS’s coverage of glucose testing supplies is not aligned with eligibility requirements for diabetes devices. More importantly, eligibility requirements and coverage lag behind the evolving evidence of their effectiveness ( 15 , 16 ).…”

Section: Focus Area 2: Diabetes Devicesmentioning

confidence: 99%

The National Clinical Care Commission Report to Congress: Leveraging Federal Policies and Programs to Improve Diabetes Treatment and Reduce Complications

Greenlee¹,

Bolen

Chong

et al. 2023

Diabetes Care

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The Treatment and Complications subcommittee of the National Clinical Care Commission focused on factors likely to improve the delivery of high-quality care to all people with diabetes. The gap between available resources and the needs of people living with diabetes adversely impacts both treatment and outcomes. The Commission’s recommendations are designed to bridge this gap. At the patient level, the Commission recommends reducing barriers and streamlining administrative processes to improve access to diabetes self-management training, diabetes devices, virtual care, and insulin. At the practice level, we recommend enhancing programs that support team-based care and developing capacity to support technology-enabled mentoring interventions. At the health system level, we recommend that the Department of Health and Human Services routinely assess the needs of the health care workforce and ensure funding of training programs directed to meet those needs. At the health policy level, we recommend establishing a process to identify and ensure pre-deductible insurance coverage for high-value diabetes treatments and services and developing a quality measure that reduces risk of hypoglycemia and enhances patient safety. We also identified several areas that need additional research, such as studying the barriers to uptake of diabetes self-management education and support, exploring methods to implement team-based care, and evaluating the importance of digital connectivity as a social determinant of health. The Commission strongly encourages Congress, the Department of Health and Human Services, and other federal departments and agencies to take swift action to implement these recommendations to improve health outcomes and quality of life among people living with diabetes.

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What's Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring

Cited by 28 publications

References 76 publications

Broadening Access to Continuous Glucose Monitoring for Patients With Type 2 Diabetes

Broadening Access to Continuous Glucose Monitoring for Patients With Type 2 Diabetes

Barriers to Uptake of Insulin Technologies and Novel Solutions

The National Clinical Care Commission Report to Congress: Leveraging Federal Policies and Programs to Improve Diabetes Treatment and Reduce Complications

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