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Review
. 2021 Sep;23(9):652-660.
doi: 10.1089/dia.2021.0107. Epub 2021 Apr 27.

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

Rodolfo J Galindo  1   2   3 , Christopher G Parkin  4 , Grazia Aleppo  5 , Anders L Carlson  6   7   8   9 , Davida F Kruger  10 , Carol J Levy  11   12 , Guillermo E Umpierrez  13   14 , Janet B McGill  15
Affiliations
Review

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

Rodolfo J Galindo et al. Diabetes Technol Ther. 2021 Sep.

Abstract

Numerous studies have demonstrated the clinical value of continuous glucose monitoring (CGM) in type 1 diabetes and type 2 diabetes populations. However, the eligibility criteria for CGM coverage required by the Centers for Medicare & Medicaid Services (CMS) ignore conclusive evidence that supports CGM use in various diabetes populations that are currently deemed ineligible. This article discusses the limitations and inconsistencies of the CMS eligibility criteria relative to current scientific evidence and proposes workable solutions to address this issue and improve the safety and care of all individuals with diabetes.

Keywords: Centers for Medicare & Medicaid Services; Continuous glucose monitoring; Insurance coverage; Type 1 diabetes; Type 2 diabetes.

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Conflict of interest statement

R.J.G. has received unrestricted research support to Emory for investigator-initiated studies from Novo Nordisk and Dexcom, Inc., and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly, BI, and Valeritas. R.J.G. is partially supported by research grants from NIH/NIDDK P30DK11102 and 1K23DK123384-01. C.G.P. has received consulting fees from Abbott Diabetes Care, CeQur SA, Dexcom, Inc., Onduo, Roche Diabetes Care; and Novo Nordisk. G.A. has received research support from AstraZeneca, Dexcom, Eli Lilly, Insulet, Novo Nordisk, and is a consultant for Dexcom and Insulet. A.L.C. has received research support from UnitedHealthcare, Abbott, Dexcom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, and Sanofi, and is a consultant for Medtronic and Insulet, with all financial support going to his institution. In addition, A.L.C. has a patent, Treatment of Hypoglycemia Unawareness with Intranasal Insulin, pending to HealthPartners Institute. D.F.K. has served on advisory boards and/or speaker bureaus for Dexcom and Abbott Diabetes Care, and her institution has received research support from Dexcom. C.J.L. reports grants from Abbott Diabetes, Dexcom, Insulet and Senseonics paid to her institution, non-financial device support from Dexcom and Abbott Diabetes, service as a consultant for Sanofi, Eli Lilly and Dexcom, and other support from Novo Nordisk outside the submitted work. G.E.U. is partly supported by research grants from the NIH/NATS UL1 TR002378 and 1P30DK111024-05, and P30DK111024-05S and has received unrestricted research support (to Emory University) from Astra Zeneca, Novo Nordisk, and Dexcom. J.B.M. reports consulting fees from Bayer, Boehringer Ingelheim, Lilly, Metavant, and Salix as well as research funding grants from Dexcom, Medtronic, and Novo Nordisk.

Figures

FIG. 1.
FIG. 1.
Diabetes prevalence within the Medicare population by race/ethnicity.
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention (CDC): National Diabetes Statistics Report, 2020: Estimates of diabetes and Its Burden in the United States. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-stat... (accessed February29, 2020)
    1. Centers for Disease Control and Prevention: Diabetes Prevalence and Incidence Among Medicare Beneficiaries—United States, 2001–2015. https://www.cdc.gov/mmwr/volumes/68/wr/mm6843a2.htm (accessed February26, 2021)
    1. Kaiser Family Foundation: Racial and Ethnic Health Inequities and Medicare. February 2021. http://files.kff.org/attachment/Report-Racial-and-Ethnic-Health-Inequiti... (accessed February25, 2021)
    1. Teigland C, Pulungan Z, Shah T, et al. : As It Grows, Medicare Advantage Is Enrolling More Low-Income and Medically Complex Beneficiaries. The Commonwealth Fund May 13, 2020. https://www.commonwealthfund.org/publications/issue-briefs/2020/may/medi... (accessed February26, 2021)
    1. U.S. Food & Drug Administration: Fighting Diabetes' Deadly Impact on Minorities. April 10, 2020. https://www.fda.gov/consumers/consumer-updates/fighting-diabetes-deadly-... (accessed February7, 2021)

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