For many patients with chronic kidney disease (CKD), food insecurity is a persistent threat to their health. Combating this issue is an association called the Food Is Medicine Coalition (FIMC), whose members provide medically tailored meals that meet the nutritional needs of kidney patients. Coalition members are also examining the positive impact that specific programs have on patient outcomes, healthcare utilization, and the cost of care. Recent studies reveal practical opportunities for healthcare providers and payors to collaborate with community groups and to integrate medically tailored meals into comprehensive treatment programs.
Food insecurity is a global problem affecting an estimated 1 billion people.1 There is enough food in the world for everyone, but issues with local food availability, food access, and food utilization result in over 800 million undernourished people worldwide.2,3 Asia Pacific and sub-Saharan Africa are most heavily impacted. Previously, global efforts to increase food production of grain staples prevented millions of deaths.4 But this "calories-first" approach has resulted in the emergence of obesity and related chronic diseases, such as diabetes mellitus and hypertension. Today, the focus of food security solutions has shifted to producing nutritionally rich fruits and vegetables. The World Health Organization, along with science and health advocates, supports new guidelines to encourage people to "eat a variety of real foods, mostly plants" to optimize health.5
Social determinants of health such as housing, community, kinetics, intellectual purpose, and food security are central to Fresenius Medical Care North America's innovative clinical programs. In the United States, social determinants of health are key drivers in health outcomes and cost. Proportionally, direct healthcare is estimated to impact only 10 percent of outcomes compared to behavioral patterns, social circumstances, and environmental exposures, which impact 60 percent.6 This is especially true in kidney disease where the majority of patients starting dialysis represent racial and ethnic minorities who lack access to adequate healthcare resources.7 Disparities in CKD incidence, progression, and treatment are associated with social determinants including socioeconomic status and home neighborhood.8 Albuminuria, low estimated glomerular filtration rate, and end stage renal disease (ESRD) rates are highest in the poorest neighborhoods.9
In 2013, an estimated 14.3 percent of American households faced economic instability resulting in food insecurity.10 Low income and food insecurity are associated with chronic diseases including diabetes mellitus, hypertension, and obesity as well as CKD and ESRD. Poor access to food increases the risk of not only CKD, but also CKD progression.11 Studies show that food insecurity in America results in the intake of calorie-dense foods with high starch, added sugar, and added saturated fats, leading to overnutrition (an overabundance of nutrients that don't support normal growth and development).12
The type of food matters. The Dietary Approaches to Stop Hypertension (DASH) diet intervention, which is rich in fruits and vegetables and low in saturated fats, lowers blood pressure and decreases CKD progression.13 Patients with CKD have higher survival rates when adhering to a diet high in fiber and polyunsaturated fats and low in salt, phosphorus, and acid load.14 A diet with a high acid load (less fruits and vegetables) increases CKD progression risk.15
Can dietary intervention for CKD patients with food insecurity be a treatment to slow CKD progression and decrease the incidence of ESRD?
FIMC is an association of nonprofit medically tailored food and nutrition service providers. Agencies within FIMC have partnered with external researchers to develop rigorous evidence demonstrating that medically tailored meals improve health outcomes, reduce total medical expenses, and improve quality of life for individuals facing complex chronic illnesses, including CKD.
Medically tailored meals—an evidence-based nutritional intervention—are custom-made for an individual's specific medical condition(s) and delivered to that person's home. Registered dietitian nutritionists customize these meals to address the primary condition, co-occurring illnesses, and medication considerations. For example, the meal could address diabetes, cardiovascular disease, and CKD. Patients who stand to gain the most from medically tailored meals are those with one or more complex chronic conditions, and who typically face food insecurity and other challenges gaining access to or preparing nutritious meals.
Two clinical research studies published in 2018—led by the nonprofit Community Servings of Boston, a leading member of FIMC, in partnership with Dr. Seth Berkowitz, formerly of Massachusetts General Hospital and now at the University of North Carolina Medical School—evaluated the impact of medically tailored meals on health outcomes, healthcare utilization, and costs. Researchers found that medically tailored meals improve diet quality, while reducing healthcare utilization and costs, for individuals with complex chronic illnesses and poverty.
The first 2018 study, published in Health Affairs, a leading health policy journal, examined the impact of home-delivered meals on adults who were dually eligible for Medicaid and Medicare; the meals were reimbursed by a community-based health plan (Commonwealth Care Alliance). The study focused on two meal programs: medically tailored meals provided by Community Servings and a non-tailored food program provided by a Meals on Wheels vendor. Researchers demonstrated an average monthly net reduction (factoring in the cost of the meals) of 16 percent in medical costs for individuals receiving medically tailored meals versus a matched control group. It showed that the average monthly medical cost for patients receiving medically tailored meals was $843 versus $1,463 for the control group, a gross savings of $540 per month—factoring in the cost of the meals, a net savings of $220 per month. Medically tailored meal participants also experienced statistically significant reductions in emergency room visits, inpatient admissions, and emergency transportation services.16
The second study, published in the Journal of General Internal Medicine in November 2018, tested whether the receipt of medically tailored meals improved dietary quality for food-insecure patients with advanced diabetes (A1C >8). The study was designed as a crossover trial in which participants were randomly assigned the order of "on meals" (home delivery of 10 meals per week for 12 weeks) and "off meals" (12 weeks of usual care). After 12 weeks, the "on meal" and "off meal" groups crossed over. Researchers utilized the Healthy Eating Index (HEI) as a measure to assess whether individuals experienced improvements in dietary quality, an essential factor in diabetes management.
A clinically meaningful difference in the HEI is 5 points. The average "on meal" HEI score was 71.3 while the average "off meal" HEI score was 39.9, a difference of 31.4 points. The "on meal" group also reported lower food insecurity, less hypoglycemia, and fewer days where mental health was an issue in daily life than the "off meal" group.17
Since the publication of these two studies, there have been emerging opportunities to integrate medically tailored meals into healthcare payment and delivery systems. For example, beginning in 2020, accountable care organizations within the Massachusetts Medicaid (MassHealth) program will have access to funds through the Flexible Services Program to spend on nutrition and housing support services to qualifying members. Similar opportunities to integrate medically tailored meals into treatment plans for individuals on Medicaid are emerging in New York, California, Colorado, North Carolina, and other parts of the country that are moving toward models of value based payments. Also beginning in 2020, Medicare Advantage Supplemental Benefits will reimburse for nutrition services for individuals coping with complex chronic illnesses.
In preparation for meeting these changes, providers of medically tailored meals must overcome operational, logistical, and financial challenges. Community Servings recently invested in its infrastructure in order to contract with a leading Medicare Advantage plan. Because Community Servings receives patient information, it had to develop processes compliant with HIPAA and other data privacy requirements. To potentially partner with the MassHealth Flexible Services Program, Community Servings also developed the capacity to ship meals. It is now able to provide meals to any individual in Massachusetts, a requirement of Medicaid.
Community Servings is somewhat unique in its ability to invest in its infrastructure to meet new challenges in partnership with healthcare payors. Payors should consider investing in the community by joining community-based organizations that are typically resource-challenged but have the expertise to provide needed social services. The most successful social determinants programs—which comprehensively and equitably address patients' social needs—will emerge from a fully collaborative process in which healthcare payors and providers work with community-based organizations on all aspects of program design and execution, such as:
Medically tailored meals and family food security may improve outcomes for patients with CKD. Interconnecting providers, payors, and community resources is complex, but it creates an innovative partnership to improve the lives of CKD patients (Figure 1).
FIGURE 1 | Impact of diet on the risk of developing CKD and progression from CKD to ESRD
DUGAN MADDUX, MD, PhD, FACP
Vice President, Kidney Disease Initiatives, Fresenius Medical Care
Nephrologist Dugan Maddux champions FMCNA's clinical innovation endeavors and is co-founder of the Gamewood companies, including Acumen Physician Solutions. Blogger, writer, and essayist, she developed the Nephrology Oral History project chronicling early dialysis pioneers. She holds her bachelor's degree in chemistry from Vanderbilt University and her doctor of medicine from the University of North Carolina at Chapel Hill.
DAVID B. WATERS
Chief Executive Officer, Community Servings
David Waters, an advocate for integrating medically tailored meals into the healthcare system, has formed partnerships with leading healthcare payors and providers to better link clinical care and social services, designing some of the country's first health insurance contracts for prescription meals. He is the former board chair of the Association of Nutrition Service Agencies and is a leading member of the national Food Is Medicine Coalition as well as the Root Cause Coalition. In recognition of his leadership at Community Servings and within the Greater Boston community, David was named a Barr Foundation Fellow in 2017. A resident of Cambridge, he holds graduate degrees from Middlebury College and Boston University.