Officials at Omada Health said the PREDICTS trial was planned long before CMS decided not to include virtual providers in this spring's launch of the Medicare Diabetes Prevention Program. But a spokesperson said the company hopes the growing body of evidence in support of virtual programs will "assuage any concerns."
A new clinical trial launched Monday by digital health provider Omada Health will go beyond tracking changes in weight and blood sugar for people with prediabetes—it will also track how much healthcare participants use, a key measure that should be of interest to payers.
Omada’s announcement comes amid an explosion in digital health technology, one in which payers—including Medicare and Medicaid—are increasingly looking for high-quality clinical evidence from providers of diabetes prevention and management programs. But payers also want to know the bottom line: will an intervention save money?
Omada Health’s program is one of the better-known digital options for delivering the National Diabetes Prevention Program (DPP), an evidence-based curriculum developed by CDC that has been shown to reduce the likelihood of progressing to diabetes by 58% for patients with clinical indicators that show they are at risk. While the National DPP was originally delivered only in face-to-face settings, digital-based “virtual” providers have emerged over the past decade, offering the promise of scaling the program to much larger populations and reaching people in remote locations.
“Our goal at Omada has been to continually set new standards for what the industry should expect when it comes to the effectiveness of digital healthcare interventions,” said Omada co-founder and CEO Sean Duffy in a statement emailed to The American Journal of Managed Care®.
While Omada Health has conducted 9 peer-reviewed studies, this will be the first time it will measure the program’s direct effect on healthcare utilization within a peer-reviewed trial, according to Adam Brickman, senior director of strategic communications and public policy for Omada Health. “We are looking to more rigorously quantify some of the positive health effects we’ve seen anecdotally in commercial deployments,” Brickman said.
CMS dealt these virtual providers a blow in 2017, when it declined to fully include them in the launch of Medicare DPP, set for April 1, 2018. Instead, virtual providers can only offer up to 4 make-up sessions to Medicare beneficiaries, with CMS saying it will gather more evidence before including virtual providers in the future. The decision came despite virtual providers’ growing footprint in commercial plans and their track record with the CDC, which also acts as the certifying body for the National DPP.
Called PREDICTS (Preventing Diabetes With Digital Health and Coaching for Translation and Scalability), the trial will enroll approximately 500 participants who meet CDC criteria for enrollment in the National DPP, according to Omada’s statement. Participants will enroll at the University of Nebraska Medical Center (UNMC) and be randomly assigned to either Omada’s virtual program or clinical care at UNMC.
According to the statement, UNMC will lead data collection and “study the implementation process,” while a separate set of researchers at Wake Forest University will be tasked with “data system management, quality operational reports, evaluation, and analysis.”
“Omada will run the experimental arm of the trial and provide engagement and outcome data for the analysis,” the statement said.
Measures to be recorded include: weight gain or loss, change in glycated hemoglobin (A1C), quality-of-life measures, stress levels, healthcare utilization, and other measures. According to Brickman, healthcare utilization will be measured with a combination of claims analysis and self-reports, using the University of California at San Diego healthcare utilization survey.
When former HHS Secretary Sylvia Mathews Burwell announced in March 2016 that Medicare would start paying for the DPP, she didn’t just cite the clinical outcomes that showed an average weight loss of 5.17% for those who attended 9 sessions—she cited an average Medicare savings of $2650 over 15 months. That was based on a face-to-face pilot with the YMCA. CMS has said it wants to conduct a separate pilot with the virtual providers, who have said there’s already plenty of data to support reimbursement.
Brickman emphasized that planning for PREDICTS was under way long before CMS issued its final decision on the role of virtual providers in Medicare DPP, and “nothing in the trial is being measured specifically in response to the CMS decision,” he said.
Also, PREDICTS will cover a range of age groups, not just seniors, he said. Still, “Omada believes that a growing body of evidence on virtual DPP effectiveness will continue to assuage any concerns by CMS on the effectiveness of the intervention,” Brickman said in an email. “Again, we hope a continually growing body of evidence among all virtual DPP providers will address CMS concerns.”