U.S. CMS Raises Three Key Concerns on Digital Diabetes Prevention Programs—Where Lies the Opportunity?

Launched in the form of mobile applications, online education, and behavioral coaching for weight loss and healthy lifestyles.Virtual Diabetes Prevention Programdigital health companies have demonstrated their value. The Diabetes Prevention Program is gaining increasing popularity, with a growing body of research on its efficacy, and collaborations between digital health companies and vendors are continuously strengthening. However, the Centers for Medicare and Medicaid Services (CMS) believes that individualized diabetes prevention programs still require further improvement.

Although the final version of the “2017 Physician Fee Schedule” issued by CMS explicitly states that it will advance Medicare coverage for diabetes prevention programs, CMS has not yetDigital Diabetes Prevention ProgramProvide clear stipulations. In the final rule, CMS stated: “We currently do not have sufficient information to adjudicate this proposal, but we hope to continue collecting more information on the virtual delivery of DPP (Diabetes Prevention Program) services.”

So, what information do they actually need, and what does this mean for digital health companies? Several industry leaders weighed in on the matter, and VCBeat (WeChat ID: vcbeat) has compiled their insights. We seek to determine whether the CMS’s recent ruling signals that digital products have yet to meet the required standards, or whether it presents an opportunity for digital health companies to demonstrate their social value.

First, the Centers for Medicare & Medicaid Services (CMS) is planning to incorporate all Diabetes Prevention Programs into its regulations. The Centers for Disease Control and Prevention (CDC) is leveraging funding from the Affordable Care Act to develop chronic disease management programs. These initiatives aim to assist approximately 86 million Americans with prediabetes through health education, lifestyle modifications, and behavioral changes. Given the vast population base, digital health companies have become essential means of scaling these programs.

“Adam Brickman, Health Director of Omada Strategic Communications and Public Policy, stated, ‘If the United States had not passed the ACA (Affordable Care Act), our company would not exist. A theory has been proposed regarding large-scale institutional change: we tend to overestimate short-term impacts while underestimating long-term effects.’”

Thus, we established the Diabetes Prevention Committee and expandedDPP（Diabetes Prevention Program）scope of application. In this process, digital health companies have also played an important role. Brenda Schmidt, CEO of Solera, serves as the acting chair of the committee, with both Solera and Retrofit being founding members. Solera is essentially a marketplace that connects various DPP providers with consumers and employers seeking to offer DPPs to their employees.

However, Brickman stated that the CMS still needs to obtain more information in three key areas to decide whether to approve the digital health program, namely:How to Implement Digital Diabetes Prevention Programs, Their Efficacy, and Risks and Challenges During Implementation。

“DDP（Diabetes Prevention Program) How does it work? The in-person prevention program is conceptually easy to understand. You come to a specific location once a week for a one-hour session, then weigh yourself and track your weight-loss progress. “The digital program operates somewhat differently,” Brickman said. “You can access and participate in sessions at any time during the week. Therefore, our progress is measured by course completion rather than by hours.”

Once the metrics are established, CMS needs to design methods to evaluate their effectiveness. Brickman stated that the next critical issue they need to address, one shared by both digital and traditional health plans, is integrity.

“CMS has keenly identified an issue: we should identify areas with a high incidence of fraud and abuse, and strive to mitigate and prevent such occurrences,” he said.

The Diabetes Prevention Program, first proven effective in 2010, is a community-led program consisting of weekly group sessions. Currently, many through the CDC (U.S. Centers for Disease Control and Prevention) certified community programs are very similar to it. Meanwhile, companies such as Omada Health, Retrofit, Canary Health, and HealthSlate are developing digital or semi-digital health programs.

These plans will utilize connected scales and activity trackers to monitor participants’ progress, along with text messaging and video capabilities to facilitate virtual coaching sessions, while leveraging mobile social tools for sharing updates. In an interview, Brickman outlined several benefits of digital interventions.

“Many people are eager to join such health programs, but find it difficult to integrate structured, in-person health programs into their daily lives,” he said. “You can think of several reasons: single parents, working parents, those living in rural areas with limited access to community centers, older adults, individuals with mobility impairments, or low-income populations. These are the drawbacks of traditional in-person DPPs, whereas virtual health programs do not have such issues.”

Beyond usability, Brickman believes that digital prevention programs also facilitate the large-scale adoption of the Diabetes Prevention Program (DPP) among patients with diabetes. Schmidt, CEO of Solera, expressed skepticism about this view.

“For me, digitalization is simply another way to meet people’s unique needs and preferences,” she said. “Community-based service models can cater to at least 80% of consumers.”

On the contrary, Schmidt believes that the key to scaling up lies in expanding the delivery channels for the Diabetes Prevention Program (DPP). In addition to the YMCA, churches, schools, grocery stores, and pharmacies should also offer similar services.

"Interestingly,Large retail pharmacies and grocery chains may become the next frontier,” she said. “We aim to deliver DPP services where people live, work, play, and pray, which is why we have established partnerships with the United Methodist Church, retail pharmacies, and grocery stores. So, where do populations tend to congregate? And how can we deliver DPP in innovative ways to lower barriers to participation?”

Solera’s business model empowers individuals to choose the format of their Diabetes Prevention Program (DPP). She noted that, based on their experience, preferences are evenly split between in-person and virtual health programs. However, Adam Kaufman, CEO of Canary Health, stated that company data show most people tend to prefer digital health programs when given a choice. In a six-month study conducted in collaboration with Stanford University, five out of six participants chose the digital diabetes prevention program when offered the option between in-person and virtual programs.

“Consumers prefer digital plans because they are easier to integrate into their lives,” he said. “People do not adhere to the physiological measurement methods we employ; instead, they consider factors such as lifestyle, sources of fear, and elements that affect their quality of life.”

This 12-month study is nearing its conclusion, and Kaufman also hopes to see similar research outcomes. Kaufman stated, “We are very optimistic about obtaining more evidence regarding efficacy; CMS simply requires additional evidence, so we must continue conducting trials and research.”

However, Schmidt is uncertain whether most older adults—a population affected by Medicare reimbursement policies—are ready to embrace digital interventions. She believes that Solera’s experience also supports this view. Yet this remains a point of contention. Omada Health found in a recent study that older adults demonstrated high engagement in its program.

Brickman stated, “Believe it or not, our elderly clients achieve the best training outcomes. I acknowledge that some older adults prefer in-person learning, but our senior group demonstrates the highest engagement and the most favorable participation results.”

Brickman believes that digital programs have advantages over real-world programs: we can achieve new innovations based on factors such as demographics or geography, for example, using big data to develop personalized plans for specific participants.

“Our data science team is conducting experiments within the company’s system. This system helps health coaches identify users who require additional support and care, as well as determine the types of assistance most likely to benefit them. For instance, if I were a health coach and one of my participants failed to submit weight metrics, complete workouts, or log into the system, the Omada data science team would alert me: ‘Hey, Jim Smith needs some extra attention.’ Meanwhile, based on program data from thousands of users similar to Jim Smith, we can specify which interactions are most likely to help Jim Smith get back on track.”

Brickman believes that current service efficiency can be further improved. “In the next phase, our DPP will vary based on individual users,” he said. “Understanding behavioral science is a challenging process involving privacy concerns, so we believe personalization is crucial.””

Omada Diabetes Prevention Program has receivedCDC (U.S. Centers for Disease Control and Prevention)recognition, which means they can register as DPP providers covered by health insurance, but they represent only a small minority. Among the 1,200 DPPs nationwide in China, only 77 diabetes prevention programs have received CDC recognition. Of these, only a small fraction are digital programs.

Schmidt stated that from now until the CMS finalizes its regulations in 2018, the Innovation Center for Agents has a valuable opportunity to examine how digital companies validate their work, and to leverage these insights to benchmark against existing programs and refine their approaches.

“The typical model of the DPP involves initial classification followed by a course of treatment. I look forward to further redefinition of the activities and requirements for participants and patients on digital platforms in the future, as well as gaining clarity on how CMS diligently collects such data,” Schmidt responded.

Solera provides a platform for DPPs that connects employers with taxpayers, and it is currently in negotiations with the CMS Innovation Center to validate its role as an integrated platform. Schmidt stated that achieving such significant advancements requires legislative changes to be just as important as technological innovation, with a clear focus on treating chronic disease management holistically.

“We will see whether CMMI has the authority to designate Solera’s integrative role as a Medicare provider within the Medicare program. What is certain is that if legislation is required to establish Solera as an integrated platform, it would definitely not be disease-specific,” she said. “We know it cannot be limited to diabetes alone. As we consider these preventive services in Medicare, they span the entire Medicare landscape and pave the way for this model to serve as a complement to primary care, thereby meeting the needs of high-acuity patients.”

Schmidt stated that it is time for the company to take the CDC list of approved projects seriously, and for CMS to accurately define what they aim to achieve through digital initiatives—particularly in healthcare, where even technologies with seemingly limitless scope have their limits.

“Currently, Solera has hundreds of institutions and over 10,000 in-network providers dedicated solely to meeting the needs of the commercial population,” said Schmidt. “We recognize that thousands more institutions will be needed in the future to serve this population. Whether you are a community-based provider or a digital vendor, you remain constrained by human resource capacity when it comes to lifestyle coaching. As long as a lifestyle coach is required, digital solutions alone cannot address scalability challenges. Therefore, due to current workforce limitations, no single DPP vendor—not even digital ones—can fully meet the demand.”

Mary Pigatti, CEO of Retrofit, stated that even a less definitive ruling represents a significant advancement for digital health initiatives.

“We are pleased to hear about the CMS developments, and we are glad to have the opportunity to discuss this issue,” said Pigatti. “We do not believe that this ruling will ban digital health companies, as no final decision has been made yet. I think we are currently in a good position. We have evidence to demonstrate our trustworthiness. What you will see is greater transparency. More rulemaking is already underway to determine how to implement the new policies.”

Therefore, by January 1, 2018, health insurance was highly likely to cover all types of Diabetes Prevention Programs (DPPs)—including both digital and in-person programs. What would happen after that? For instance, for those without health insurance, when would such reimbursement become widely available? In such cases, individual payment typically follows government reimbursement, said Schmidt. However, DPPs have demonstrated that this model is somewhat unique.

“The market shows that when CMS covers DPP, commercial plans follow,” she said. “We have already seen commercial payers take the lead. By 2017, Solera will have signed contracts with most payers.”

“It is too early to tell whether individual taxpayers currently see enough ROI from the benefits to continue with this project, as they have decisively outmaneuvered the government and are seriously committed to it,” said Schmidt.

“They are making every effort to get members to sign contracts,” she said. “Take Blue Shield of California, for example: they send us a complete application package every week and help us leverage these members for recruitment. So this is not just something they pay lip service to; they are truly proactive in carrying it out because they believe in the potential of the research findings.”

Brickman stated that Omada’s experience shows only a few forward-thinking payers have entered into partnerships with them, including integrated systems such as Kaiser Permanente and traditional payers like Humana.

But in reality, the answer to “What’s next?” is this: The significance of the insurance reimbursement pilot for preventive care programs may extend far beyond diabetes. Schmidt believes this could mark the beginning of an entirely new medical model.

“I believe the way they have structured these incentives sets a precedent for other general preventive care programs within the community,” she said. “From CMS’s perspective, this is not a disease-specific profit model. It is a new approach whereby CMS addresses chronic diseases through a different type of clinical service provider, leveraging a high-access, low-cost network.”

What other preventive programs are likely to emerge? Brickman believes that diabetes prevention has already gained traction because there is a robust body of literature on its treatment protocols, and the conditions for its management are well known and easy to understand.

“If you’re part of CMS, if you’re part of HHS, and if you’re looking to move forward with your first nationwide pilot program, then the diabetes initiative is very intuitive and easy to understand,” he said. “It’s easy for us to explain this program to the general public, but it’s difficult to identify those who can reasonably prevent diabetes.”

He believes that smoking cessation could be the next preventive initiative, given its equally robust evidence base. Schmidt has her own list.

“You can consider fall prevention or arthritis management,” she said. “Of course, there are also behavioral health interventions. We even integrate social services with medical benefits for these individuals, allowing us to identify those on the verge of risk before they find themselves in dangerous situations. Currently, there are numerous evidence-based programs following similar models, and from our perspective, this is precisely why such programs are so important.”