StepOne 2023

Identifying high-potential strategies to deploy Medically Tailored Foods as a reimbursable health/medical/ insurance/wellness expense.

Open Innovation Challenge: 

Given the soaring rates of diet-driven health conditions and their spiraling care costs, utilizing food as a formal component of disease care and prevention is an emerging area of interest. This past Fall, the Biden-Harris Administration hosted a White House Conference on Hunger, Nutrition, and Health and highlighted the opportunity to combat diet-related health conditions through food-based solutions. Medically Tailored Foods (MTFs) are ready-to-eat foods designed and dosed to yield a specific health outcome, that have been proven effective via randomized controlled clinical trial(s). Despite widespread recognition that dietary change can yield health improvements and may significantly reduce care costs, foods with clinically proven health benefits have not achieved meaningful access to or coverage within health insurance or employee wellness channels. Innovation is overdue for health insurers and employers to pilot and experiment with MTFs to prevent, treat and manage diet-driven illness, especially given the failure of pharmaceuticals to stem the tide of these conditions – or keep costs down.

Reason for Seeking External Innovation Partnership:

According to the CDC, 80% of heart disease need not exist. Yet, the stark reality is that the number of patients affected is only exploding. By 2060, it is estimated that in the US alone:

  • 162 million people will be hypertensive
  • 126 million people will have hyperlipidemia
  • 55 million people will be diabetic
  • 126 million people will be obese

For insurers and self-insured employers, chronic disease accounts for the majority of their care costs. A clinical trial conducted by Mayo Clinic and University of Manitoba using MTFs offers hope and a realistic path forward. The trial demonstrated highly significant, rapid, and side-effect free cholesterol reductions in subjects following the recommended dosing of Step One Foods’ MTF products. Other health effects reported by Step One users include improved blood sugar and blood pressure control as well as weight loss, and most importantly, with sustained improvement.
Today, a physician’s only option for managing hyperlipidemia is to write a prescription for a pharmaceutical which is covered by insurance. Although it shields the patient from financial impact in the near term, this approach fails to address the underlying driver of high cholesterol (primarily diet), and leads to higher, unsustainable costs in the future.
Widespread adoption of any new treatment requires health insurance coverage. Wakely Consulting conducted an actuarial analysis to evaluate the impact of fully covering the costs of Step One’s MTFs on care costs and estimated more than $2 in savings for each $1 spent on Step One Foods. It may be novel to think about food as part of a health insurance program, but it is absolutely essential.

Scope of Solution Space:

• Reimbursement approaches for adoption within health insurance channels;

• Innovative strategies to breakthrough identified barriers; and

• Pilot opportunities with forward looking companies/programs to further validate food as medicine potential and shape potential successful programs, particularly in self-insured health plans.

Solutions Not of Interest:

The chronic disease crisis is upon us and requires immediate solutions. Options requiring years of research or tens of millions of dollars in expense, would just not be practical or have the required urgency.

Company Background:

Step One Foods is the ready to eat, Medically Tailored Food proven to positively impact health in a clinical trial conducted at Mayo Clinic and the University of Manitoba. The whole food-based products were developed by cardiologist, Elizabeth Klodas to provide the first non-pharmaceutical option to over 90 million people with hyperlipidemia, many of whom can’t or don’t want to take cholesterol-lowering medications, or struggle to improve their diet.

Every serving of Step One’s foods delivers precise doses of cholesterol-reducing whole food ingredients without requiring significant lifestyle change. The highly significant, rapid measurable health benefits demonstrated in using this cost-effective approach, provides the blueprint for sustainable, effective reductions in chronic disease rates and care expenditures.