Rule Would Limit Digital Providers to Makeup Sessions When Medicare Launches DPP in 2018

When Medicare launches the Diabetes Prevention Program (DPP) next year, digital providers can only offer makeup classes to seniors taking traditional, in-person programs, under CMS’ proposed 2018 Physician Fee Schedule (PFS). The rule would apply to digital health players that today meet the government's highest standards and offer prevention programs through commercial insurers and employers.

CMS will also delay the launch of Medicare DPP for 3 months until April 1, 2018, to let enough providers to sign up. While this delay was not unexpected, the limited role for digital providers comes as a surprise, given their expected role in scaling the program to the 22 million seniors who have prediabetes. Sources said early Friday that while the July PFS typically sets the rules for the upcoming year, digital providers have been advised that another opportunity to amend federal rules could come in November, and they still hope to be part of the 2018 launch.

The DPP is a yearlong, evidence-based lifestyle change program with a CDC-approved curriculum; it features 16 weekly core sessions, followed by a maintenance period of monthly sessions. Evidence shows the program stops prediabetes from progressing as participants make modest changes and lose 5% to 7% of body weight. In a landmark study by the National Institutes of Health, the program showed a 58% reduction in participants progressing to diabetes.

Digital (or virtual) providers worked closely with former HHS officials on the March 2016 announcement that Medicare would pay for DPP. The decision followed a successful pilot program the Center for Medicare and Medicaid Innovation (CMMI) conducted with the YMCA, which showed a savings of $2650 per beneficiary over 15 months. The finding showed that DPP could help Medicare slow spending on diabetes, which currently consumes $1 of every $3.

Under the proposed PFS, digital-only providers can be paid for up to 4 makeup sessions by partnering with a community provider that offers in-person sessions. Those relationships might make sense, since studies have shown that once DPP participants miss sessions, the inability to make them up is a chief reason people drop out of the program.

But digital providers have evidence that their programs—which typically involve working online with trained human coaches, alongside virtual support—are just as effective as in-person classes, and may be better for some. For example, most DPP participants thus far have been women, and digital programs may be a way to enroll more men.

Neal Kaufman, MD, MPH, founder and chief medical officer of Canary Health, told The American Journal of Managed Care^® in a recent interview that achieving widespread DPP delivery requires both in-person and digital programs. “Digital is ubiquitous, 24/7, the person doesn’t need to get in their car to get to the appointment. They can access it from the privacy of their home, they can come on for 5 or 10 minutes if that’s all they have that day, or they can spend an hour or longer if need be,” he said. “It identifies and helps people who don’t like to join groups.”

CMS argues that the CMMI demonstration was based on an in-person program, and that a 100% virtual DPP program is untested, at least within Medicare.

“Instead, we are considering a separate model under CMS’s Innovation Center authority to test and evaluate virtual DPP services. Our intention is that any separate model test of virtual DPP services would run in parallel with the MDPP Expanded Model. Consistent with our regular practice for Innovation Center models, we would release details on the model test for virtual DPP services separately.”

Lucia Savage, chief privacy and regulatory officer for Omada Health, said despite the surprise, it was “gratifying” to see that the evidence cited in the rule for digital programs had come from Omada.

“Part of what is going on is that they clearly want to have third-party confirmation of weight (loss),” said Savage, a former official with the Office of the National Coordinator of Health IT. “Anything that is virtual or involves telemedicine raises questions that federal officials have to think through.”

“As a taxpayer and former federal official, I understand that,” she said.

Omada Health, however, does not rely on self-reported weight—participants must stand on a scale, and their weights are recorded through a secure cell connection. Savage said that Omada will raise these points in the comment period.

Based on the proposal, Medicare might someday pay for digital DPP, but programs must prove themselves within CMMI, on top of the evidence and results many have submitted to CDC to gain program recognition. Canary Health’s program, for example is based on studies by Stanford’s Katie Lorig, DrPH, a pioneer in chronic disease management who has published work showing Canary Health’s success within a real-world health plan environment.

CDC’s recognition process serves as a signal to payers, and the proposed rule requires progress toward recognition for Medicare payment. CDC has awarded full recognition to several online programs, including Omada Health, Canary Health, and Noom. All have published papers in peer-reviewed journals.

The proposed PFS makes other changes that promise more flexibility to Medicare clients—notably a maintenance period that can last up to 2 years if the person meets weight loss and attendance goals. There’s strong emphasis on performance-based payment, with a detailed schedule of fees for different benchmarks. CMS has called for 50% of Medicare payments to be value-based by 2018.

Brenda Schmidt, CEO of the integrator Solera Health, said in a statement Friday that the company "recognizes the need for evidence-based results to inform the inclusion of virtual DPPs and looks forward to working with CMS and virtual providers to develop this option in the near future." Solera Health works with both community-based and digital DPP programs, and the company has long advocated letting consumers choose programs that suit their individual needs.