Lost in Translation: A Disconnect Between the Science and Medicare Coverage Criteria for Continuous Subcutaneous Insulin Infusion

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Abstract

Numerous studies have demonstrated the clinical value and safety of insulin pump therapy in type 1 diabetes and type 2 diabetes populations. However, the eligibility criteria for insulin pump coverage required by the Centers for Medicare & Medicaid Services (CMS) discount conclusive evidence that supports insulin pump use in diabetes populations that are currently deemed ineligible. This article discusses the limitations and inconsistencies of the insulin pump 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.

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Most cited references 94

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Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)

(1998)

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10-year follow-up of intensive glucose control in type 2 diabetes.

Rury R Holman, Sanjoy K Paul, M Angelyn Bethel … (2008)

During the United Kingdom Prospective Diabetes Study (UKPDS), patients with type 2 diabetes mellitus who received intensive glucose therapy had a lower risk of microvascular complications than did those receiving conventional dietary therapy. We conducted post-trial monitoring to determine whether this improved glucose control persisted and whether such therapy had a long-term effect on macrovascular outcomes. Of 5102 patients with newly diagnosed type 2 diabetes, 4209 were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin) for glucose control. In post-trial monitoring, 3277 patients were asked to attend annual UKPDS clinics for 5 years, but no attempts were made to maintain their previously assigned therapies. Annual questionnaires were used to follow patients who were unable to attend the clinics, and all patients in years 6 to 10 were assessed through questionnaires. We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories. Between-group differences in glycated hemoglobin levels were lost after the first year. In the sulfonylurea-insulin group, relative reductions in risk persisted at 10 years for any diabetes-related end point (9%, P=0.04) and microvascular disease (24%, P=0.001), and risk reductions for myocardial infarction (15%, P=0.01) and death from any cause (13%, P=0.007) emerged over time, as more events occurred. In the metformin group, significant risk reductions persisted for any diabetes-related end point (21%, P=0.01), myocardial infarction (33%, P=0.005), and death from any cause (27%, P=0.002). Despite an early loss of glycemic differences, a continued reduction in microvascular risk and emergent risk reductions for myocardial infarction and death from any cause were observed during 10 years of post-trial follow-up. A continued benefit after metformin therapy was evident among overweight patients. (UKPDS 80; Current Controlled Trials number, ISRCTN75451837.) 2008 Massachusetts Medical Society

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Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Melanie Davies, David A. D’Alessio, Judith Fradkin … (2018)

The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication, and surgical interventions, are recommended. With regards to medication management, for patients with clinical cardiovascular disease, a sodium–glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide 1 (GLP-1) receptor agonist with proven cardiovascular benefit is recommended. For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1 receptor agonists are generally recommended as the first injectable medication.

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Author and article information

Journal

Journal ID (nlm-ta): Diabetes Technol Ther

Journal ID (iso-abbrev): Diabetes Technol Ther

Journal ID (publisher-id): dia

Title: Diabetes Technology & Therapeutics

Publisher: Mary Ann Liebert, Inc., publishers ( 140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA )

ISSN (Print): 1520-9156

ISSN (Electronic): 1557-8593

Publication date (Print): October 2021

Publication date (Electronic): 30 September 2021

Publication date PMC-release: 30 September 2021

Volume: 23

Issue: 10

Pages: 715-725

Affiliations

[ ¹ ]Division of Endocrinology, Metabolism and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.

[ ² ]Clinical Research, CGParkin Communications, Inc., Henderson, Nevada, USA.

[ ³ ]International Diabetes Center, Endocrinologist, Regions Hospital & HealthPartners Clinics, Minneapolis, Minnesota, USA.

[ ⁴ ]Diabetes Education Programs, HealthPartners and Stillwater Medical Group, Minneapolis, Minnesota, USA.

[ ⁵ ]University of Minnesota Medical School, Minneapolis, Minnesota, USA.

[ ⁶ ]Emory University School of Medicine, Atlanta, Georgia, USA.

[ ⁷ ]Center for Diabetes Metabolism Research Emory University Hospital Midtown, Atlanta, Georgia, USA.

[ ⁸ ]Hospital Diabetes Taskforce, Emory Healthcare System, Atlanta, Georgia, USA.

[ ⁹ ]Division of Endocrinology, Diabetes, Bone & Mineral, Henry Ford Health System, Detroit, Michigan, USA.

[ ¹⁰ ]Division of Endocrinology, Diabetes, and Metabolism, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.

[ ¹¹ ]Mount Sinai Diabetes Center and T1D Clinical Research, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.

[ ¹² ]Division of Endocrinology, Metabolism Emory University School of Medicine, Atlanta, Georgia, USA.

[ ¹³ ]Diabetes and Endocrinology, Grady Memorial Hospital, Atlanta, Georgia, USA.

[ ¹⁴ ]Barbara Davis Center, Division of Pediatric Endocrinology, Department of Pediatrics, University of Colorado Denver, Denver, Colorado, USA.

[ ¹⁵ ]Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, School of Medicine, St. Louis, Missouri, USA.

Author notes

[*]Address correspondence to: Christopher G. Parkin, MS, Clinical Research, CGParkin Communications, Inc., 2352 Martinique Avenue, Henderson, NV 89044, USA. chris@ 123456cgparkin.org

ⁱORCID ID ( https://orcid.org/0000-0001-6838-5355).

ⁱⁱORCID ID ( https://orcid.org/0000-0002-9295-3225).

ⁱⁱⁱORCID ID ( https://orcid.org/0000-0003-3607-9788).

^ivORCID ID ( https://orcid.org/0000-0002-6228-6521).

Author information

Christopher G. Parkin https://orcid.org/0000-0001-6838-5355

Rodolfo J. Galindo https://orcid.org/0000-0002-9295-3225

Gregory P. Forlenza https://orcid.org/0000-0003-3607-9788

Janet B. McGill https://orcid.org/0000-0002-6228-6521

Article

Publisher ID: 10.1089/dia.2021.0196

DOI: 10.1089/dia.2021.0196

PMC ID: 8573795

PubMed ID: 34077674

SO-VID: 599b8a97-11b1-4bc4-9ea6-fcc6e72e0e4d

License:

This Open Access article is distributed under the terms of the Creative Commons License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

Lost in Translation: A Disconnect Between the Science and Medicare Coverage Criteria for Continuous Subcutaneous Insulin Infusion

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GLUT4 biology

Most cited references 94

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)

10-year follow-up of intensive glucose control in type 2 diabetes.

Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

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