Digital health companies offering virtual diabetes prevention programs – in the form of app or web education and coaching to support weight loss and other healthy lifestyle behaviors – have already proven their worth, as evidenced by their increasing popularity with consumers, the growing number of efficacy studies, and their partnerships with providers. But, in the eyes of the Centers for Medicare and Medicaid Services, they still have some catching up to do with in-person prevention programs.
While made clear it would move forward with extending Medicare coverage to diabetes prevention programs, the parameters for how digital versions would be included remain unclear.
“We do not have enough information to finalize this proposal at this time, but expect to continue gathering more information on the virtual delivery of DPP services,” CMS wrote in the final rule.
So what kind of information do they need, and what does this mean for digital health companies moving forward? We spoke with a few industry leaders to assess whether the CMS ruling sends a signal that digital offerings aren’t up to par, or whether it presents an opportunity for digital health companies to demonstrate just how big of a role they have to play.
To begin with, that CMS is covering Diabetes Prevention Programs at all. Borne out of the Affordable Care Act’s allocation of money to the Centers for Disease Control to develop programs for managing chronic illnesses, the program aims to reach some 86 million people in the United States with prediabetes through education, lifestyle and behavioral changes. Considering the sheer scope of that population, digital health companies have emerged as an obvious means of extending the reach of programs.
“Our company would not exist had the ACA not passed,” Omada Health Director of Strategic Communications and Public Policy, told Babyforyou.net.ua. "Adam Brickman. “There’s a theory, it’s about large-scale systems change. We overestimate the impact in the short term and we underestimate the long-term impact.”
Building on that, we saw the formation of the Council for Diabetes Prevention to expand access to DPPs, and digital health companies were a big part of that – Solera CEO Brenda Schmidt is the acting president, and the company was a founding member along with Retrofit. Solera is essentially a marketplace that connects different DPPs to payers and employers looking to offer them to their populations.
But to fully embrace digital programs, CMS will need more information across three key areas, Brickman said: how they are conducted, how well do they work, and what are the risks and challenges to running a digital diabetes prevention program?
“How do digital programs actually work? In-person programs are very easy to conceptualize. You come to a specific location for one hour a week, you sit through a class, you weigh in, and you track progress. Digital programs we do a little bit differently,” said Brickman. “Once the week starts, you can access and take part in the lesson at any time of your choosing. So instead of it being a one-hour block when you attend a session, our progress is measured in lesson completion.”
Once the metrics are down, the CMS will need to devise ways to rate their effectiveness. Next, Brickman said, they need to more on an issue that cuts across both digital and in-person programs: integrity.
“One thing CMS has a really keen eye for is ‘What are the areas where fraud and abuse are possible and how do we mitigate and prevent that?’” he said.
What does digital bring to the table?
The original Diabetes Prevention Program that proved efficacy in 2010 was an in-person community-driven program, a curriculum for once-a-week meetings with group classes. And many of the community programs that are currently certified by the CDC are quite similar. But companies like Omada Health, Retrofit, Canary Health, HealthSlate and others are developing digital, or partially digital versions of the program.
These programs involve connected weight scales and activity trackers to track participants' progress, text messaging and video to facilitate meetings with coaches, and mobile social tools to replicate the social dynamic. Brickman, at Omada, laid out several of the benefits to a digital intervention in an interview with Babyforyou.net.ua.
"There’s a huge population that is eager to engage in a program like this, but has difficulty fitting the structured in-person version of it into their daily lives," he said. "And you can think of a few reasons: single parent, working parent, someone in a rural area without easy access to a community center, if you’re a senior or you have mobility issues or you’re low income. These are all populations that in-person DPP may actually have barriers to access that virtual ones don’t."
In addition to access issues, Brickman believes digital programs are also the secret to scaling DPP across the large population of prediabetics. Solera CEO Schmidt is more skeptical on that point.
"Digital to me is just another way of potentially meeting people’s unique needs and preferences," she told Babyforyou.net.ua. "Eighty percent of the market at least could be met with a community-based delivery model."
Instead, Schmidt thinks the secret to scalability is broadening what kinds of community sites offer DPPs -- not just the YMCA, but churches, schools, grocery stores and pharmacies.
"What’s been interesting is large retail pharmacy and grocery chains are probably the next frontier," she said. "We want DPP to be in the way. We want the delivery to be where people live, work, play and pray. So we have a relationship with the United Methodist Church. We have relationships with retail pharmacy and grocery. If you think about where people are, how can we deliver DPP in novel ways and make it easier for people to participate?"
Solera's business model revolves around giving people choices about how to do the DPP -- she says that, in their experience, people's preferences are about 50/50 brick and mortar to digital. But Canary Health CEO Adam Kaufman says their data shows people, when given the choice, gravitate toward digital a lot of the time. In a six-month study done in collaboration with Stanford, he said, participants were given a choice of a brick and mortar program or a virtual one, and five out of six chose the digital diabetes prevention program.
“Consumers are ready for digital programs because they can use them the way that fits into their life,” he said. “People don’t think in the physiological measures that we have compartmentalized them into; they think terms of how they live their lives, what causes them fear, what impacts the quality of their life.”
The 12-month results of that study will soon be released, and Kaufman expects to see more of the same.
“We’re cautiously optimistic that all the evidence around efficacy is actually out there, but they [CMS] just haven’t seen enough of it yet, so we all have to continue to run trials and studies,” said Kaufman.
In particular, Schmidt isn't sure seniors -- the group affected by a Medicare reimbursement -- are, by and large, ready for a digital intervention. She says that Solera's experience bears that out. But that's also a point of some contention. Omada found in a recent study that seniors were some of their best participants.
"Believe it or not, seniors are the group with which we get the best results," Brickman said. "I do fully agree that there are some seniors who are going to want to do it in person. But the seniors we’ve enrolled get better engagement and outcome results than any other group we’ve worked with."
Brickman thinks digital has one more advantage over brick and mortar: it enables new innovations such as using big data to personalize the program for particular participants, based on factors like demographics or geography.
"We have a whole data science team running experiments in our system that can flag for our health coaches who might be struggling, who might need extra attention, and what type of attention that person is most likely to benefit from. So if I’m a health coach and one of my participants is not weighing in or not doing lessons or not logging on, not only do I get a ping from the Omada data science team, saying hey Jim Smith could use some extra attention, but we can be kind of prescriptive about what kind of interaction is most likely to help Jim Smith get back on track based on the hundreds of thousands of patients like Jim Smith who have been through the program previously.”
Brickman thinks this could improve efficacy even further.
"The next phase of the DPP as it evolves is to become a slightly different program based on the individual user," he said. "What we know about behavioral science is a deeply personal and a deeply difficult process. So in order to unlock the key we think that personalization is going to be critical."
Challenges to implementation of digital reimbursement
Omada’s diabetes prevention program has been recognized by the CDC, meaning they can enroll as a Medicare-covered DPP supplier, but they represent a minority. Of the 1,200 total DPP in the country, only 77 diabetes prevention programs are recognized by the CDC. And very few of those are digital programs.
Schmidt said the time between now and when CMS finalizes the rules in 2018 is a good opportunity for the agency’s Innovation Center to see how digital companies are validating their work, as well as develop ways to compare it to brick and mortar programs.
“The typical paradigm for a DPP was a group class, and you attended a session. I’m anticipating that there will be a further definition of the activities and engagements that would be required of a member or a patient in a digital platform and how CMS is contemplating collecting that data,” Schmidt told Babyforyou.net.ua.
Solera, which offers a marketplace connecting employers and payers to DPPs, has been in talks with the CMS Innovation Center to vet out its role as an integrator. To make these sorts of leaps, Schmidt said, legislative changes will be just as important as technology innovation, and it will have to focus on chronic disease management as a whole.
“We will see if CMMI has the authority to designate Solera’s integrator role as a Medicare supplier across Medicare, because certainly if they needed to introduce legislation for Solera as an integrator, it couldn’t be disease-specific,” she said. “It couldn’t just be for diabetes. And we know as we’re thinking of these preventative services in Medicare, it’s across Medicare and paves the way for this model as an adjunct to primary care to meet the needs of seniors who are at risk.”
Schmidt said this is the time for companies to get serious about getting on CDC’s list of approved programs, and for CMS to define exactly what they want from digital programs, especially since even the seemingly limitless reach of technology can only go so far when it comes to healthcare.
“Solera right now has hundreds of organizations in our network and well over 10,000 delivery locations just to try to meet the needs of the commercial population,” Schmidt said. “We recognize it’s going to take thousands more to meet demands. And whether you are a community organization or a digital provider, you still have a human capacity constrained in a lifestyle coach. Digital doesn’t solve for scale as long as you need a coach. So there’s no single DPP provider or even a digital provider that can meet demand because of human capacity constraints."
Mary Pigatti, CEO of Retrofit, said even the less-than-clear ruling is a huge step forward for digital programs.
“We are excited to hear about CMS even talking about this, and we are excited at the opportunity to take on this issue,” Pigatti told Babyforyou.net.ua. "We don’t think that the ruling is such that it is going to leave out digital health companies – no final decision was made – and I think we are sitting in a very good position. We have the credentials to show that we are solid. I think what you are going to see now is additional clarity, there’s more rulemaking to finalize how to enforce new policy.”
What’s next -- Private payers and other preventative programs
So in all likelihood, Medicare will reimburse all kinds of DPP -- digital and in-person -- come January 1, 2018. What happens after that?
Well for one, there's the question of when this reimbursement will be widespread for those not insured by Medicare. In cases like this, private payers often follow after the government, Schmidt said. But DPP has proved a little unusual in that way.
"The market felt that with CMS covering the DPP, the commercial plans would follow," she said. "We’ve seen the commercial payers lead. Solera will be contracted with the majority of large national payers by 2017."
While it's still too early to tell if those private payers are seeing enough ROI from the benefit to continue with it, they have beaten the goverrnment to the punch, and they are seriously committed to it, Schmidt said.
"They’re extremely engaged in getting their members enrolled," she said. "For instance Blue Shield of California is sending us their entire eligibility file every week and helping us leverage those members for enrollment. So it’s not just something that they’re paying lip service to as a benefit, they’re really actively engaged because they believe in the potential for the outcome based on the studies."
Brickman said that Omada's experience is that it's only a handful of forward-thinking private payers that have signed on to work with them, including integrated systems like Kaiser Permanente, as well as traditional payers like Humana.
But the real answer to the "What's next?" question is this: The import of this experiment with Medicare reimbursement for a preventative program could be more far-reaching than the diabetes. Schmidt says it could be the beginning of a whole new paradigm in medicine.
"I think that the way they’re structuring this benefit is designed to be the precedent for other prevention programs delivered in the community and generally," she said. "So from CMS’s perspective, this is not a disease-specific benefit. This is a new way CMS is looking at addressing chronic conditions through a different type of nonclinical provider through a high access, low-cost network."
What other preventative programs could come next? Well Brickman says that diabetes has emerged because robust literature exists on the therapy and the condition is well known and easy to understand.
"If you are CMS, if you are HHS, and you’re going to move forward with your first nationwide expansion of a pilot program, diabetes is a very intuitive and understandable one," he said. "It is easy to explain to the general public and it’s difficult to find those that are reasonably against preventing diabetes."
He thinks smoking cessation could be the next preventative program to follow suit, since its evidence base is similarly robust. Schmidt had her own list.
"So some of the things you could think about would be fall prevention, or arthritis management," she said. "Certainly some behavioral health interventions. Even integration of social services into medical benefits for these folks, where we can find people who are at-risk before they are in crisis. There’s quite a few evidence-based programs that would follow a similar model and from our perspective, that’s why this is so important."