Skip to main content
A controlled trial of value-based insurance design - the MHealthy: Focus on Diabetes (FOD) trial
Quantitative Health Sciences Publications and Presentations
  • Alicen Spaulding, University of Michigan School of Medicine
  • A. Mark Fendrick, University of Michigan Health Systems
  • William H. Herman, University of Michigan School of Medicine
  • James G. Stevenson, University of Michigan College of Pharmacy
  • Dean G. Smith, University of Michigan School of Public Health
  • Michael E. Chernew, Harvard Medical School
  • Dawn M. Parsons, University of Michigan
  • Keith Bruhnsen, University of Michigan
  • Allison B. Rosen, University of Massachusetts Medical School
UMMS Affiliation
Department of Quantitative Health Sciences
Publication Date
Document Type

BACKGROUND: Diabetes affects over 20 million Americans, resulting in substantial morbidity, mortality, and costs. While medications are the cornerstone of secondary prevention, many evidence-based therapies are underutilized, and patients often cite out-of-pocket costs as the reason. Value-based insurance design (VBID) is a 'clinically sensitive' refinement to benefit design which links patient cost-sharing to therapy value; the more clinically beneficial (and valuable) a therapy is for a patient, the lower that patient's cost-sharing should be. We describe the design and implementation of MHealthy: Focus on Diabetes (FOD), a prospective, controlled trial of targeted co-payment reductions for high value, underutilized therapies for individuals with diabetes.

METHODS: The FOD trial includes 2,507 employees and dependents with diabetes insured by one large employer. Approximately 81% are enrolled in a single independent-practice association model health maintenance organization. The control group includes 8,637 patients with diabetes covered by other employers and enrolled in the same managed care organization. Both groups received written materials about the importance of adherence to secondary prevention therapies, while only the intervention group received targeted co-payment reductions for glycemic agents, antihypertensives, lipid-lowering agents, antidepressants, and diabetic eye exams. Primary outcomes include medication uptake and adherence. Secondary outcomes include health care utilization and expenditures. An interrupted time series, control group design will allow rigorous assessment of the intervention's impact, while controlling for unrelated temporal trends. Individual patient-level baseline data are presented.

DISCUSSION: To our knowledge, this is the first prospective controlled trial of co-payment reductions targeted to high-value services for high-risk patients. It will provide important information on feasibility of implementation and effectiveness of VBID in a real-world setting. This program has the potential for broad dissemination to other employers and insurers wishing to improve the value of their health care spending.

Rights and Permissions
© 2009 Spaulding et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI of Published Version
Implement Sci. 2009 Apr 7;4:19. Link to article on publisher's site
PubMed ID
Related Resources
Link to Article in PubMed
Citation Information
Alicen Spaulding, A. Mark Fendrick, William H. Herman, James G. Stevenson, et al.. "A controlled trial of value-based insurance design - the MHealthy: Focus on Diabetes (FOD) trial" Vol. 4 (2009) ISSN: 1748-5908 (Linking)
Available at: