Startups have been lobbying for federal policymakers to allow Medicare reimbursement for virtual and digital diabetes prevention programs—particularly in light of the COVID-19 crisis.
Now, digital health startup Lark Health says it has new evidence behind its virtual diabetes prevention program (DPP) when it comes to reaching vulnerable patients and keeping them healthy at home.
Lark Health is an integrated chronic care management platform that uses artificial intelligence to help patients make the necessary behavior changes needed to manage their conditions actually stick.
Launched in 2011, Lark's platform has since grown to reach nearly 2 million people to support managing their diabetes, weight loss, hypertension, and behavioral health needs. Patients are provided with connected devices they can use to monitor their condition, and that data is then translated into individualized health insights.
A study released Monday found participants using Lark’s diabetes prevention program experienced an average weight loss of 10.4 pounds, or 4.3% of body weight, after completing the year-long program.
Lark’s research team examined their results after one year of participating in Lark’s diabetes program and found that the average weight loss for users located in health provider shortage areas (HPSA) was 4.3%. Currently, close to one-quarter of the U.S. population (23.6%) lives in an officially designated HPSA, a designation given to geographic regions with a shortage of primary care providers. These results are on par with similar studies of Lark’s DPP, in which participants saw an average weight loss of 4.2% after one year.
RELATED: COVID-19 is changing everything. Here's what that means for diabetes
Delivering care virtually to at-risk populations is more important than ever during the COVID-19 pandemic.
People with underlying conditions have been shown to be more vulnerable to serious COVID-19 symptoms: one study of COVID-19 patients showed that nearly 50% of those hospitalized had
hypertension. The CDC also reported that 78% of all ICU patients have underlying conditions, and another study revealed that COVID-19 patients with diabetes were significantly more likely to develop pneumonia.
The Centers for Medicare and Medicaid Services (CMS) has opened up access to telehealth during the health crisis, including waiving certain Medicare telehealth payment requirements to enable telehealth services to be provided in all settings. Companies like Lark Health hope CMS will shift its policy on online diabetes prevention programs.
"CMS (the Centers for Medicare and Medicaid Services) only reimburse for in-person programs, and unfortunately, HPSA groups often don’t have local nearby programs and no one wants to go to a hospital right now. So you have this compounding problem, as virtual DPP providers like us can infinitely scale and care for tens of millions of pre-diabetics and chronic patients," Hu said.
In October, 19 U.S. senators sent a letter (PDF) HHS Secretary Alex Azar and CMS Administrator Seema Verma asking them to make CDC-recognized virtual care providers eligible for Medicare reimbursement in the Medicare Diabetes Prevention Program expanded model.
Some stakeholders argue that including virtual care services could improve access to the Medicare Diabetes Prevention Program for millions of Americans. Politico has reported that the program has struggled as few Medicare beneficiaries are accessing the DPP, well below the tens of thousands that had been expected to take advantage of the program
Back in February, Politico reported that CMS Administrator Seema Verma sent a letter to Congress in response saying CMS is “currently exploring ways” to support virtual care reimbursement.
Virtual care can help keep those at greater risk of complications healthy and at home, Hu noted.
RELATED: Docs could face looming health crisis as COVID-19 disrupts care for chronically ill
"This demonstrates the impact of virtual health and especially in the time of COVID. My hope is that the government, as its progressing, takes a look at regulations that will allow virtual DPP providers to provide care and take on that additional chronic burden that is being placed on the system by COVID," she said.
Earlier this year, the company’s diabetes prevention program received Full Recognition status from the Centers for Disease Control and Prevention, which is the highest level of recognition from the agency.
Startup Omada Health also has gained full recognition status from the CDC for its DPP program, as well as Fruit Street Health.
Weight loss is used as a clinical proxy for diabetes prevention program effectiveness, as obesity is closely related to insulin sensitivity, blood glucose control, and risk for type 2 diabetes, according to the company. "Vulnerable populations living in HPSAs lack access to consistent primary care, but our virtual DPP is delivering long-term health and weight loss results, reducing their risk of type-2 diabetes,” Hu said.
Lacking easy access to a primary care provider is a challenge for some, but can be especially devastating to those suffering from or at risk of developing diabetes, Hu said. Out of the about 25,0000 participants enrolled in Lark’s DPP, more than half reside in areas with insufficient access to primary care providers, according to the company.
Technology can help to break down those barriers, she said. "We offer a 24/7 'coach' on your smartphone in your pocket. It's appealing and accessible to the broader population," she said.