- Digital diabetes coaching providers are joining forces in an effort to convince the Centers for Medicare and Medicaid Services to include mHealth in the Medicare Diabetes Prevention Program.
Some virtual coaching is included in the MDPP, which was unveiled in early 2016 following a successful pilot conducted by the CMS Innovation Center and is slated to become a fully reimbursed Medicare program beginning in April 2018. But CMS has said it won’t cover virtual programs that focus on self-reported weight measurements because “self-reported weight loss is not reliable for the purposes of performance payment."
That’s disappointing news for Mary Pigatti, CEO of RetroFit, who feels virtual diabetes coaching programs are as effective as in-person programs – and better for Medicare beneficiaries with mobility, transportation or access issues.
Without effective lifestyle intervention strategies, as many as 30 percent of people with prediabetes will develop type 2 diabetes within five years, according to the CDC. Studies have shown that lifestyle intervention strategies like the MDPP can reduce the risk of people developing type 2 diabetes by some 58 percent.
According to CMS, Medicare spent $42 billion more in 2016 on beneficiaries with diabetes than it would have spent if they hadn’t developed diabetes. That amounts to, per beneficiary, an estimated $1,500 more on Part D prescription drugs, $3,100 more for hospital and facility services and $2,700 more in physician and other clinical services.
Pigatti said the MDPP is “a tremendous step forward” in health and wellness, but CMS needs to broaden its reach to include more mHealth and telehealth programs.
“A program is a program whether it’s being delivered in person or [on a telehealth platform] – the only difference is the delivery method,” said Pigatti, who is also the working lead for the Council for Diabetes Prevention’s Digital Working Group.
CMS “has expanded coverage that will help reduce chronic diseases” and healthcare costs associated with type 2 diabetes, she said. “That’s great. They’re already part-way there. They just need to get all the way there.”
Also expressing displeasure was Omada Health, which has long argued that mHealth programs can reach millions of pre-diabetic people who wouldn’t be able to attend in-person programs. Omada, which has funded or participated in nine peer-reviewed trials proving the efficacy of digital platforms, was “surprised and disappointed” by the CMS announcement, privacy officer Lucia Savage told Politico.
The proposed MDPP Expanded Model, published July 13 in the Federal Register, proposes policies to further define the set of MDPP services, beneficiary eligibility criteria and supplier eligibility and enrollment criteria. Comments on the proposal will be received by CMS through Sept. 11.
The MDPP expanded model is a “structured intervention with the goal of preventing type 2 diabetes in individuals with an indication of prediabetes,” CMS states. “The clinical intervention consists of a minimum of 16 intensive “core” sessions of a Centers for Disease Control and Prevention (CDC) approved curriculum furnished over six months in a group-based, classroom-style setting that provides practical training in long-term dietary change, increased physical activity and behavior change strategies for weight control.”
“After the completing the core sessions, less intensive follow-up meetings furnished monthly help ensure that the participants maintain healthy behaviors,” CMS says. “The primary goal of the expanded model is at least 5 percent average weight loss by participants.”
The program is based on the National Diabetes Prevention Program, a study funded by the a National Institutes of Health (NIH) which found that lifestyle changes that helped cause “modest weight loss” could significantly curb type 2 diabetes in people deemed to be at high risk of developing the chronic condition.
Pigatti, who says she’s “really excited” that CMS is including some mHealth in its expansion of the MDPP, notes that both CMS and the CDC have recognized the value of virtual visits.
“They have recognized the clinically proven efficacy” of programs like RetroFit’s, she said, noting patients in her company’s program have averaged a 6 percent reduction in weight over the first six months and an average 7 percent weight loss over 12 months. “They have recognized that we are all delivering broad outcomes and we are sustainable.”
Among the options CMS is considering is a separate pilot program, developed through the Innovation Center, that would focus on virtual coaching programs targeting weight loss. Pigatti said such a pilot program wouldn’t be rejected by mHealth companies offering such services, but she feels the evidence has already been presented to prove that virtual coaching works.
“We’re got to get [CMS] to understand that [virtual coaching] is the same program that everyone else if delivering in person,” she said. “It’s just a different delivery method.”
Pigatti said several mHealth companies are banding together to deliver comments to CMS asking that virtual coaching programs focusing on weight loss be included in the MDPP.
The Council for Diabetes Prevention, a non-profit launched in 2016 to support the National Diabetes Prevention Program, is also preparing comments. The council is comprised of more than 30 members, including founding members RetroFit, Solera Health, the Skinny Gene Project, the Black Women's Health Imperative, Valley Jewish Community Center, Baptist Medical Group, A Vision of Health, Fundamental Health Solutions, Urban Health Resource and Integrative CAP Health Practices.
“We’re not waiting. We’re trying to influence the final regulations,” she said.