History Lessons in Innovation: Digital Behavioral Medicine Can Address the Diabetes "Double Epidemic" Facing Medicare and America's Seniors

May 24, 2016
Mike Payne, MBA, MSci

Evidence-Based Diabetes Management, May 2016, Volume 22, Issue SP7

Now that Medicare is poised to pay for the Diabetes Prevention Program, the next question is how to make it scalable.

In 1941, Australian pharmacologist and pathologist Howard Florey demonstrated—for the first time—an effective process for the mass production of penicillin, the antibiotic commonly referred to as the “first wonder drug.” Although Sir Alexander Fleming discovered penicillin in 1928, it was actually Florey’s methods for large-scale production of the mold P. chrysogenum that fully unlocked the potential of the drug. His work, and the large-scale production by US companies, came just in time to address a widespread epidemic of bacterial disease proliferated by the carnage of World War II. In the 25 years following 1943, the prevalence and incidence of serious bacterial infection in the United States plummeted—a true inflection point in the epidemiology of infectious disease, largely brought about by Florey’s scaling innovation (FIGURE).

Seventy-five years after Florey’s ground-breaking discovery, society is facing a new epidemic. However, this time it is “metabolic” disease, characterized in affected patients by abnormal levels of sugar and certain hormones in the blood, leading to (and, in turn, perpetuated by) excess body weight. These conditions are most prominently affected by human behavior and consumption. Abnormal blood sugar and associated issues predispose people to obesity and type 2 diabetes (T2D), chronic conditions the CDC labeled “the public health challenge of the 21st century” in 2009.1

In the context of this new epidemic, March 23, 2016, may well be remembered as a day that the largest healthcare payer in the United States took a critical step toward, driving an inflection point similar to that seen in the early 1940s with infectious disease.

On that date, HHS Secretary Sylvia Mathews Burwell declared that the delivery of the Diabetes Prevention Program (DPP) has been certified as both clinically effective and cost saving when delivered to Medicare beneficiaries. She further suggested that CMS would soon provide reimbursement for administration of DPP to Medicare beneficiaries.2

To understand the potential impact of Secretary Burwell’s landmark announcement, we must first understand the true scope of the epidemic, as well as the critical role that a new innovation called “digital behavioral medicine” can play in scaling these interventions.2

Since 2011, baby boomers have aged into Medicare at the rate of about 10,000 per day.3 Today, there are almost 45 million individuals aged 65 and older in the United States. By 2030, the US Census Bureau projects that number will be nearly 73 million.4 Given these projections, Medicare enrollment in that year will be equal to a quarter of the entire US population today.

Coupled with this demographic mega-trend are clinical dynamics that make the situation even more frightening: more than half of those over 65—a population of more than 22 million—already have prediabetes,5 and every year, up to 10% of this population will progress to T2D. The CDC estimates that 1 in 3 American adults will have T2D by 2050.6 More than one-third of those older than age 65 also have some form of heart disease,7 a condition closely correlated to prediabetes.

In 2014, Medicare spent more than $15,700 managing the health of each beneficiary with diabetes, which included 991 annual emergency department (ED) visits for every 1000 beneficiaries with the condition and a 30-day readmission rate of 20%.8 The numbers related to heart failure—often closely correlated with T2D profiles—were even worse: Medicare annually spends more than $41,000 on those beneficiaries, who average 1657 ED admissions per 1000 beneficiaries, with a 30-day readmission rate of 24%. The Diabetes Care Project already estimates than 1 in every 3 Medicare dollars is spent treating beneficiaries with diabetes.9

The parallels between cardiometabolic chronic disease in the 21st century and infectious disease at the dawn of the 20th century are evident—this time, with a medical expense epidemic accompanying the clinical one. How can today’s healthcare leaders address both?

The answer lies in prevention, to mitigate both medical impact and the bulk of expense. Fortunately, appropriate clinical interventions have been shown to significantly lower the risk of T2D for those at risk. In 2002, the National Institutes of Health (NIH) published results of a clinical trial that demonstrated the effectiveness of the DPP, a behavioral intervention, in helping patients lose clinically meaningful amounts of body weight, reduce their blood sugar levels, and lower the risk for diabetes by 58%.10

Secretary Burwell’s DPP announcement implies that the NIH’s clinical work, along with recent efforts by CMS to show the medical expense impact of DPP, provide the evidence base that DPP may play a key role in addressing the diabetes “double epidemic” of disease and cost.11, 12

For the past 3 years, the Center for Medicare & Medicaid Innovation (CMMI) has operated a demonstration project at 17 YMCA sites in 8 states. In the project, the Y administered the DPP to more than 77,000 seniors who had been diagnosed with prediabetes.12 Payments to the YMCA were dependent on how many sessions beneficiaries attended and what percentage of body weight—a recognized indicator of downstream diabetes risk reduction—those participants lost. In the final evaluation, the CMS Office of the Actuary estimated that the intervention ultimately saved Medicare $2650 per beneficiary in just 15 months..13

However, Secretary Burwell’s announcement of the CMMI/YMCA project’s excellent results does not alone guarantee victory in the battle against diabetes and its associated costs. The combination of the original NIH trial and the CMMI/YMCA project included approximately 9000 individuals with prediabetes, just 0.01% of the total US population with prediabetes. DPP delivered face-to-face- to YMCAs, churches, clinics, and other community settings will be difficult to scale to 22 million Americans seniors—let alone the additional 65 million Americans who also have prediabetes.

Digital behavioral medicine may hold the answer to this problem of clinical impact and cost-effectiveness at scale. In fact, it may be the equivalent of Florey’s scaling methods that supported the production of 646 billion penicillin doses annually by 1945, up from fewer than 10 doses in 1942.

Broadly defined, digital behavioral medicine refers to the digitally-enabled delivery and continuous improvement of proven effective lifestyle interventions like the DPP, while maintaining a high level of clinical fidelity to the original research. For the past 5 years, Omada Health has done just that, developing a version of the DPP, which it delivered remotely, and leveraging insights about behavioral design, user experience, and data science to layer an already effective program with predictive analytics and personalization. Today, we are the largest CDC-recognized14 provider of the DPP in the country, in-person or remote, with an enrollment of more than 55,000 participants across all 50 states.

Most relevantly, Omada Health’s results with seniors indicate that digital delivery of the DPP can and should be an essential part of Medicare’s DPP expansion. Administering the DPP digitally can scale the program to the scope of the problem, by lowering barriers to access and success, and by ensuring that this program reaches the populations which need it the most.

To date, Omada Health has enrolled more than 2000 participants over the age of 65. Overall, 84% of these participants, with an average age of 69, have remained active in the program after 6 months. More impressively, they’ve lost an average of 7.8% of their body weight, reducing their 3-year risk of developing T2D by more than 58%. Every day, our data science, product, and engineering teams are refining the program to adapt it for seniors’ lifestyles, stimulate even more engagement, and generate better clinical outcomes. Digital behavioral medicine has far-ranging implications for seniors with prediabetes, as well as all those at elevated risk of an entire suite of obesity-related chronic diseases.

For the first time in history, demographic trends are forcing a fundamental rethinking of how we orient care in our public payer programs like Medicare. The current administration—and hopefully the next—has shown a willingness to embrace prevention strategies, as well as nontraditional online providers of DPP that can demonstrate excellent clinical outcomes and program integrity at scale.

At Omada Health, it is not lost upon us that Florey’s penicillin-based innovations are credited with saving over 82 million lives. This number is tantalizingly close to the 87 million Americans currently living with prediabetes. We are invigorated by the vision that in 30 years, we will look at an epidemiological graph showing a drastic drop in US T2D incidence starting in 2018 and know that, like those penicillin pioneers, our innovative approach to delivery of a proven health intervention had a truly historic impact of the health of this country.

Mike Payne, MBA, MSci, is chief healthcare development officer at Omada Health. References

1. The power of prevention: chronic disease—the public health challenge of the 21st century. CDC website. http://www.cdc.gov/chronicdisease/pdf/2009-Power-of-Prevention.pdf. Published 2009. Accessed May 4, 2016.

2. Independent experts confirm diabetes prevention model supported by Affordable Care Act saves money [press release]. Washington, DC: HHS newsroom; March 23, 2016. http://www. hhs.gov/about/news/2016/03/23/independent-experts-confirm-diabetes-prevention-modelsupported-affordable-care-act-saves-money.html. Accessed May 4, 2016.

3. Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System, Chapter 2: the next generation of Medicare beneficiaries. http://www. medpac.gov/documents/reports/chapter-2-the-next-generation-of-medicare-beneficiaries-%28june-2015-report%29.pdf?sfvrsn=. Published June 2015. Accessed May 4, 2016.

4. Vincent GK, Velkoff VA. The next four decades: the older population in the United States, 2010 to 2050. US Census Bureau website. https://www.census.gov/prod/2010pubs/p25- 1138.pdf. Published May 2010. Accessed May 4, 2016.

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7. Go AS, Mozaffarian D, Roger VL, et al; American Heart Association Statistics Committee andvStroke Statistics Subcommittee. Older Americans and cardiovascular diseases. American Heart Association website. https://www.heart.org/idc/groups/heart-public/@wcm/@sop/@smd/documents/downloadable/ucm_319574.pdf. Published 2013. Accessed May 4, 2016.

8. Chronic conditions. CMS website. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Chronic-Conditions/CC_Main.html. Updated January 7, 2016. Accessed May 4, 2016.

9. Diabetes fast facts. The Diabetes Care Project website. http://www.diabetescareproject.org/diabetes-fast-facts.html. Updated 2013. Accessed May 4, 2016.

10. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle

intervention or metformin. N Engl J Med. 2002;346(6):393-403.

11. About the CMS Innovation Center. CMS website. https://innovation.cms.gov/about/index. html. Accessed May 4, 2016.

12. Hinnant L, Razi S, Lewis R, et al. Evaluation of the healthcare innovation awards: community resource planning, prevention and monitoring, annual report 2015. Awardee-level findings: YMCA of the USA. CMS website. https://innovation.cms.gov/Files/reports/hcia-ymcadppevalrpt.pdf. Published March 2016.

13. Certification of the Medicare Diabetes Prevention Program. Office of the Actuary. CMS website. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/Actuarial- Studies/Downloads/Diabetes-Prevention-Certification-2016-03-14.pdf. Published March 14, 2016. Accessed May 4, 2016.

14. Research-based prevention program. CDC website. http://www.cdc.gov/diabetes/prevention/prediabetes-type2/preventing.html. Updated January 14, 2016. Accessed May 4, 2016.