Innovations In Diabetes Care Around the World: Case Studies Of Care Transformation Through Accountable Care Reforms

Diabetes mellitus affects 8.3 percent of the world’s population, and over 80 percent of the estimated 380 million adults living with diabetes reside in low- or middle-income countries. ^1,2 Nearly half of the people with diabetes worldwide are undiagnosed, and there are high rates of missed opportunities to detect and treat diabetes and address risk factors earlier to prevent the onset of disease. ³

Failures to address risk factors or effectively manage other conditions associated with diabetes, such as coronary artery disease or renal failure, lead to premature mortality and disability. This results in high direct medical costs and high indirect social costs of diabetes care, including lost labor productivity and reduced national output. ^4,5 Furthermore, diabetes prevention and treatment may be viewed as an “indicator” condition for the capacity of a nation’s health care system to address the rising burden of noncommunicable diseases. ⁶

Consequently, innovations in diabetes prevention and management in development or use today have important implications for public health and health care costs. ⁵ Many innovations in diabetes prevention and treatment involve alternatives to traditional medical treatment, such as team-based care strategies, remote monitoring, the use of analytic tools that guide treatment via patient data, and the coordinated use of community services.

Physician groups, private and public payers, and entrepreneurial organizations are developing these kinds of innovative care models to achieve better health outcomes at lower costs. Typically, these innovations are developed locally, and they are often based on empirical evidence from similar innovations tried elsewhere, particularly for community-based or information technology innovations. Attention to local conditions is critical for reforms in care. ⁷ However, the diffusion of successful innovations, through either scaling up or replication in a different setting, represents a potentially faster and less costly way to affect outcomes than does the invention of new care models. Yet of the many promising innovations in diabetes care that have been developed, only a fraction have been widely adopted. ^7–9

A variety of business and consumer challenges to successful innovation in health care exist, including the need to obtain investment funding and to improve consumer awareness and perception and the lack of distribution infrastructure. Previous studies have noted the importance of public policies in health care innovation, especially highlighting regulatory and financial policies. ^10–15 Nonetheless, few studies have focused on how policies could have an impact on innovations, particularly those that involve new business models, or on how innovators can best address such policy impacts.

For example, medical services must generally be provided by licensed professionals who have restrictions on where and how they may legally provide the services, which affects innovations that use community or telehealth services. Additionally, the United States and other countries have “supply-driven” financing systems that pay for the volume of activities and do not generally reimburse nontraditional types of services.

Such challenges are not unique to developed countries. Emerging markets have public financing streams and regulatory systems that may create barriers and opportunities for diffusing new care models. In turn, these barriers are not unique to diabetes. Policies may create additional difficulties in achieving, scaling up, and sustaining many disruptive innovations in health care. ¹¹

Background On Accountable Care Reforms

Responding to new opportunities to improve health outcomes and reduce costs from innovation in health care, many countries are adopting accountable care reforms to promote higher-value care. ¹⁶ Elsewhere we have identified common characteristics of experiences with accountable care around the world. ¹⁶ We defined accountable care as holding a group of providers responsible for achieving a set of outcomes for a defined population, over a specific time period and for an agreed-on cost.

Accountable care moves away from financing and regulations for specific services and toward payments and regulations tied directly to measures of value. Payments and other policies in an accountable care framework are intended to align with value the overall package of services and care results for patients. For diabetes care, this could mean increasingly flexible financial support for wellness programs and expanded prevention, self-management tools, and care coordination for providers willing to accept new types of accountability with payments bundled at the patient level. ^17,18 As insurance benefit design is aligned with value, consumers should have more incentives to choose innovative approaches, compared to traditional care approaches.

The evidence on the benefits of accountable care is growing in the United States and other countries. Recent analyses of first-year results of Pioneer accountable care organizations (ACOs), which are fully integrated systems, show reductions in health spending growth as a result of reduced hospital admissions and avoidable complications and improved patient experience. ^19–21

However, only a fraction of organizations that participate in accountable care reforms in the United States have shown significant reductions in costs. Many ACOs with early success developed strategies locally to improve quality and reduce costs, instead of adopting available solutions. For example, the Rio Grande Valley Accountable Care Organization implemented its own spreadsheet-based program to reduce the number of patients with poor control of their diabetes (as evidenced by high hemoglobin A1C levels, an indicator of persistently high blood sugar). The ACO achieved a 7-percentage-point drop in three years by tracking the use of evidence-based diabetes care. ²²

In rural India, SughaVazhvu Healthcare developed a community-based diabetes program to increase access to integrated primary care clinics that track disease control among patients. ²³ Additionally, early results from the North West London Integrated Care Pilot show preliminary evidence of improvements in care coordination. ²⁴

As in the United States, these apparent individual successes have not been widely or easily replicated. Because these local solutions take time and effort to develop, policy reforms that could support successful innovation diffusion could represent a major opportunity for improving care. Yet few studies have examined how policy makers interested in accountable care reforms can best encourage the diffusion of valuable innovations in diabetes and other areas of care, or how innovators should account for potentially diverse policy environments when developing strategies for scaling up promising innovations.

Expanding on previous work at the Center for Health Policy at the Brookings Institution and at Innovations in Healthcare at Duke University, we used three case studies of promising innovations in diabetes care to assess policy barriers to the broad implementation of high-value innovations in such care in a diverse range of countries. The case studies involve Mexico, India, and the United States, countries with diabetes prevalence rates higher than the global average of 8.3 percent—12 percent, 9 percent, and 11 percent, respectively. ² We selected these countries because they represent diverse health systems, income levels, and social environments.

The case studies suggest key success factors for diffusing innovations in diabetes care that appear to be applicable globally, and they illustrate how accountable care reforms can sustain more cost-effective transformations of diabetes care. Based on our analysis of the case studies, we propose actions that policy makers and innovators can take to engage the public sector and begin transforming diabetes care.

Study Data And Methods

Literature Review

We conducted a guided literature review to identify diabetes care innovations in different political and economic contexts. In our review we combined the following search terms in PubMed: diabetes , diffusion , accountable care , payment reform , integrated care , innovation , disease management , wellness , and delivery reform . The search produced an initial sample of several thousand peer-reviewed articles published during 2005–15. We selected articles based on relevance, date of publication, and number of citations by other articles. We also relied on the Innovations in Healthcare diabetes working group’s database of over fifty innovative models that have been successfully scaled up, and on a library of case studies developed as part of previous work on health care delivery reform at Brookings. ^{16,22,23,25–28} We conducted an additional review of grey literature using information in the Innovations in Healthcare innovator database.

Conceptual Framework

To describe policy barriers to diffusing diabetes care innovation, we used the US Agency for International Development’s (USAID’s) idea-to-impact framework, which focuses on the process of developing, executing, and monitoring health care innovation. ⁷ The process involves four stages: identify needs and design, begin research and development, plan for introduction, and introduce and scale up.

We used previous innovation research combined with the accountable care principle of focusing on patient-level results to develop a framing of policy barriers that have an impact on population health outcomes. As noted above, previous innovation studies suggested a focus on regulatory barriers related to government approval of an innovation for marketing and use (for example, licensing), and on financial barriers related to payment in public or private health insurance systems (for example, limited or no existing coverage for the innovation). In addition, based on our previous work on accountable care case studies, we identified a third type of policy barrier: institutional. We categorized barriers as institutional if they were related to the fragmentation of regulatory and financial authorities across multiple entities (for example, separate agencies handling different components of a patient-focused innovation).

We selected case studies based on the innovation’s novelty across the continuum of diabetes care, emphasizing community-based care and new methods of electronic information technology support or teleheath, and based on its progression beyond the fourth stage in USAID’s idea-to-impact framework. We expanded the literature review to obtain more detailed information about the case studies. Because the challenges their innovators have faced are generally undocumented in the academic literature, we conducted two semistructured qualitative interviews with the organizations’ leaders to discuss policy barriers to successfully diffusing their models.

In the interviews, we asked three main questions. First, what political, organizational, and cultural challenges has the group faced when scaling up in a country? Second, has the organization addressed the challenges (or does it plan to address them)? And third, have the challenges limited the program in any way? We used published literature to supplement information gathered from the interviews.

Study Results

Community-Based And Technological Innovations In Care

The health care innovations from Mexico, India, and the United States highlighted in Exhibit 1 aim to enhance patient wellness and support diabetes prevention and management through new community-based care models and changes in information technology that extend access to services. Both the Pro Mujer program in Mexico and the YMCA Diabetes Prevention Program in the United States use existing community-based institutions to implement programs to engage patients in nonclinical settings and achieve changes in patient behavior that result in more effective prevention of diabetes complications. Pro Mujer delivers diabetes screenings, education, and health services at reduced cost to women who attend monthly microloan repayment meetings. ²⁷ The YMCA program administers a sixteen-week course that includes education and exercise support. ^29,30

Electronic health (e-health) technology using mobile or computer technology can improve patient support, increase patient access to care providers through telehealth services, and provide tools and target patients for community screenings for diabetes. ClickMedix operates e-health technology platforms in the United States, Mexico, and India to improve patient self- and team-management of diabetes care. ²⁸ ClickMedix provides opportunities for improved access for vulnerable or rural patient populations and supports teams of health workers to improve the quality of care.

Both Pro Mujer and ClickMedix offer bundled diabetes services directly to patients at a lower cost than available alternatives. ^27,28 Pro Mujer offers flexible subscription plans tied to existing microloans that cover primary care services at reduced cost.

Under ClickMedix, patients or insurance plans pay directly for single virtual consultations or monthly subscription bundles. Subscription programs support patients’ active involvement in care. The prepaid bundle moves away from payments that could be barriers at the time of care, while permitting complex and customizable sets of services. Other bundles can include clinical visits, home visits, medication, and laboratory testing for patients with diabetes or hypertension over a specified period of time. ²³

The YMCA Diabetes Prevention Program has been expanded through add-on payments by UnitedHealthcare and Medicaid. ^29,30 These supplemental payments to the YMCA are results-based: They are approximately $175 per person per sixteen-week session, dependent on the person’s achievement of weight-loss goals and class attendance. ^29,30 The additional payments allow the YMCA to offer the program to community members who cannot afford it or who are not insured by a participating payer.

Overcoming Key Policy Barriers To Diffusion

Exhibit 2 describes the experiences of the case study programs with overcoming institutional, regulatory, and financial policy barriers that can hinder the diffusion of successful care innovations. ^27–30

Institutional Barriers:

Each of these case-study innovations focused on patient-level improvements in care that spanned multiple regulatory and financing authorities and thus raised institutional concerns about how the new innovations would be regulated and reimbursed by multiple agencies and ministries or departments of health. The institutional challenges were further complicated by limited government experience with new care models.

For example, Pro Mujer in Mexico needs to resolve issues with health service regulation under the ministry of finance, since its diabetes program is operated in conjunction with financial services outside of the traditional health system. In the United States, diffusion of new care models is complicated by the federal-state split in regulatory authority, with many important authorities (for example, for e-prescribing) held by states with differing rules. Another complicating factor is the division of public financing support across different agencies, such as the Centers for Medicare and Medicaid Services (CMS) for diabetes care and the Centers for Disease Control and Prevention (CDC) for community initiatives. In India, regulatory systems are less developed, but regulatory and financing activities are mainly state based, which complicates the nationwide adoption of new care models.

Case-study program leaders responded to these institutional challenges by developing collaborations with key experienced stakeholders to increase familiarity with the innovation and to create broader support for its adoption. Collaborators included physician and health care provider groups (particularly those most advantaged by the innovation), public health and patient advocates, and sympathetic leaders in private businesses and insurers.

Partnerships also included relationships with relevant technical staff members in key government agencies at the national and local levels. For example, in Mexico, Pro Mujer and ClickMedix established partnerships with the ministry of health and regional health departments for successful scaling up. ClickMedix also partnered with the Mexican Social Security Institute to offer patient support portals in two pilots. Additionally, Pro Mujer partnered with and refers clients to regional government clinics in many locations. Pro Mujer is currently working closely with the Mexican government to establish a contract for its service delivery model that aligns the dual regulatory regimes of the ministries of health and finance.

These private-public partnerships enable incremental but meaningful policy reforms to support each innovation. While such efforts might be viewed as lobbying, in general the programs worked with field organizations and professional experts within the government instead of through professional lobbyists and political leaders.

The case studies also highlight the fact that innovation often starts and scales up in the private sector, because partnerships with the public sector can take time to develop. For example, in India, ClickMedix focused primarily on developing direct contracts with physician groups involved in diabetes care to pay for its innovation, instead of seeking government funding. In the United States, the YMCA developed a program with a private insurer in conjunction with grant funding from the CDC, given the absence of a clear pathway to payment in Medicare.

Regulatory Barriers:

Along with institutional barriers, innovators in each case study faced regulatory challenges. In India, where regulatory barriers were relatively low, market entry was less of a consideration. In Mexico, lack of clarity about not only which agency had regulatory jurisdiction but also how regulation might occur created uncertainty about program adoption. In the United States, differing state laws created challenges related to licensing and the interstate practice of medicine. In all of the case studies, the partnerships with health care providers and other stakeholders helped establish models and evidence to address regulatory concerns about the safety and effectiveness of services.

Financial Barriers:

Across the case studies, the most important policy barriers to the diffusion of new models of care were financial. There was a poor fit between the new models of care and many existing payment policies. Additionally, lack of payment support for providers could be attributed partially to uncertainty about the achievement of comparable results after scaling up and in new settings. The government collaborations in the case studies to develop pilot projects were intended to increase evidence on the cost and outcome effects of new payment models to support care transformation.

In the United States and Mexico, health care financing models established around traditional payments for medical services do not provide a straightforward path for funding many new care models. For example, in the United States, estimates from the national Diabetes Prevention Program suggest that a community program would delay the development of 885,000 new cases of diabetes and save $5.7 billion over twenty-five years if scaled up to the nation level. ³¹ Yet CMS and the Department of Veterans Affairs, two large federal agencies, lack a straightforward mechanism for redirecting funding to adopt the model. Instead, only a limited set of private payers have adopted it, and these programs still require grant support from the CDC. ²⁹

In contrast, in countries where public coverage for diabetes services was less developed and where regulatory systems allowed it, financing for the innovations we studied came directly from the private sector, through subscription payments for discrete bundles of care. In India, ClickMedix marketed its products directly to health care providers. In Mexico, Pro Mujer provides its diabetes screening and management services through a direct add-on to microfinance services.

Both innovations have used subscription models that provide a package of services with demonstrable results, and patients can stop participating if they do not receive high-quality care. While this approach helped create an initial market for the innovations and provided opportunities to refine them, the absence of public financing creates barriers to larger-scale diffusion.

Policy Reforms To Reduce Barriers To Innovation

The case studies discussed above illustrate the critical role of public policies in influencing health care innovation. Innovation may begin outside of public regulation and financing, particularly in countries with less developed public systems. But in each case we reviewed, successful scaling up would have occurred more effectively with policy reforms that provided a clearer pathway to sustainability for innovations that demonstrated improved health and reduced costs.

Based on these results and our previous experience with accountable care reforms, we have identified a set of policy reforms that would help achieve sustainable programs in a range of country contexts. These include steps that promote collaboration across stakeholders focused on higher-value care, steps to strengthen performance measures related to value, and incremental but ongoing steps to aligning different payment streams with higher-value care. We focus below on steps related to payment reform and evidence to support incremental reform, since these were most critical for accelerating the innovations described here.

Add-On Payment Or Subscription Payment

It is likely to be easier and faster to make incremental policy changes for care that crosses traditional financing and institutional lines than to make comprehensive payment or structural reforms. As illustrated by these case studies, most important are incremental financing reforms. Such reforms might include payment reform pilots with providers linked to clear performance measures, as in the YMCA program. Similarly, add-on payments to providers through medical homes or other patient-level payments tied to improved results would also promote adoption of innovations.

Subsidies to patients for their payments for promising programs would enable patients to help identify and expand promising innovations through their choices. For example, the Mexican government could consider a partial subsidy to consumers who participated in Pro Mujer’s subscription program. This add-on payment would reduce the net subscription price and thus encourage enrollment, and its continued availability could be linked to achieving better health outcomes in patients.

Accelerate Testing Of Bundled Provider Payments

Combining care bundles with diabetes-related outcome and cost measures could increase the confidence of patients and policy makers that payment reforms and disruptive innovations were leading to higher-value care. Shared savings models—such as the YMCA model, in which partial reimbursement is given only if results improved—could be implemented alongside existing systems with limited additional financial risk for the payer. These models could be a basis for shifting finances over time to a new model, one in which providers would have more of their payments tied to results than to services, along with increased regulatory flexibility to enable them to adopt innovations that improved results and lowered costs.

Integrate Payment Funding Streams For Sustainable Payment Reform

For conditions such as diabetes that entail ongoing patient engagement and behavioral change, payers and policy makers must align payment streams for medical and community-based services. One solution is a partnership between a health care payer and community-level organizations. UnitedHealthcare has successfully partnered with the YMCA to move beyond paying for traditional health care by including a results-based payment bundle for disease prevention and management services in the community. ²⁹ Building on UnitedHealthcare’s experience of expanding payment streams to include community services when tied to results, other private payers and CMS could accelerate diffusion by offering similar outcomes-based payments.

Shifting more payments to health care providers in accountable care arrangements, along with identifying best practices for providers to pay for such nontraditional services, could achieve this goal. Providers could receive an add-on payment if they used the program and their patients achieved further improvements in outcomes. By making only add-on payments, payers would face limited downside risk if the innovation did not scale up well. ClickMedix’s success with such partnerships with providers could be a model for expanding team-based, nontraditional diabetes care in the United States. Over time, the add-on payment could replace traditional service-based payments.

Institutional Reforms To Integrate Medical And Nonmedical Program Infrastructures

Some US states and localities have combined funding streams or implemented collaborations between public health and health care authorities. For countries that are still developing their public infrastructures, avoiding and minimizing such public health and health care silos in key areas of chronic disease care such as diabetes policy would be a useful step. This could even include economic development programs, with funding tied to improving diabetes care to encourage approaches such as those at Pro Mujer.

Outcomes-Based Performance Measures And Systems For Data Exchange

Policy makers can create a results-focused environment that is more favorable to disruptive innovation by holding health care providers and systems accountable for outcomes that matter to patients. For all countries, a good starting point might be strengthening the use of diabetes performance measures and key data exchange. Diabetes care is a good area to focus on initially, as diabetes is a high-burden condition in most countries, and measures of risk factors, effective treatments, and predictors of long-term outcomes (that is, glycosylated hemoglobin levels) are readily available. ClickMedix’s experience in Mexico and India shows that resource-constrained settings can use e-health to continuously measure key health indicators and exchange data across stakeholders.

Conclusion

Disruptive innovation for diabetes care is not easy, but it is essential to reducing the rising health and cost impact of the disease. Short of a cure for diabetes, biomedical innovations alone are unlikely to sustain improvements in population health. Prevention and treatment innovations are needed—and not just for diabetes, but also for other noncommunicable diseases that could benefit from similar innovations.

Although many promising innovations exist around the world, these programs are not reaching many populations that could benefit. Consequently, addressing barriers that slow the diffusion of successful innovations into new contexts is an urgent priority. By developing a framework that focused on policy barriers to innovation and applying it to diabetes care, we found evidence that effective diffusion of high-value disruptive innovation requires careful attention to policy considerations by innovators and to policy reforms by policy makers.

Future work can develop this framework and related analytic approaches, using other cases of innovation to create a more systematic and evidence-based approach. But several findings appear evident from our initial application of the framework. From the innovator standpoint, a business plan should include a practical assessment of the relevant landscape of government agencies with actual or potential relevant authority. Because disruptive patient-level innovations are not likely to be well matched to existing structures and policies, the business plan should include a mechanism for collaborating with providers, relevant patient groups, and community organizations to demonstrate the value of the innovation to regulatory entities at the state and federal level. A private-sector approach could complement this by developing evidence and refining the innovation, to the extent that such innovations are feasible and attractive to patients and providers—which in turn depends on the scope and magnitude of public regulation and financing.

For more rapid and systematic acceleration of innovation, however, further policy reforms would be beneficial in the countries we studied. Policy reforms could include steps to collect meaningful, outcome-oriented performance measures, shift provider payments toward payment that was based on these measures, and give patients with chronic diseases more control and more financial support for the bundles of chronic disease services that they chose to purchase. The steps are particularly feasible in the case of diabetes, where well-established measures exist and key data elements for tracking and improving performance have been identified. These accountable care reforms can help innovators, providers, payers, and regulators achieve their shared goal of adopting disruptive innovations that succeed in improving health and lowering health care costs around the world.

ACKNOWLEDGMENTS

The authors acknowledge the Commonwealth Fund, the Robert Wood Johnson Foundation, the Health Foundation, and the US Agency for International Development (under Cooperative Agreement No. AID-OAA-A-13-00004) for supporting part of the research reported in this article. The authors thank Jana Smith of Pro Mujer and Ting Shih of ClickMedix for providing additional material on their programs and the Accountable Care Forum Advisory Board of Qatar Foundation’s World Innovation Summit for Health and the Innovations in Healthcare’s Diabetes Working Group for their continued engagement in this area.

NOTES

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