ViVE 2023 Opens on an Upbeat Note for Digital Health Companies

Recent CMS and CDC rulings offer hope that health systems will show more love for innovative treatments like digital therapeutics and virtual platforms.

As healthcare executives and digital health companies converge on Nashville this week for ViVE 2023, the prospects for new tools like digital therapeutics and virtual technology seem to be improving.

On the heels of the Centers for Medicare & Medicaid Services' (CMS) decision to create a unique reimbursement code for digital therapeutic company AppliedVR, the Centers for Disease Control and Prevention (CDC) last week approved the use of video-based directly observed therapy (DOT) for tuberculosis treatment, saying the virtual platform could be used as an equivalent to in-person medication monitoring.

"Missed doses of medication or treatment interruptions can lead to suboptimal drug concentrations, acquired drug resistance, longer treatment times, TB treatment failure, and recurrence of TB disease," the CDC said in its March 24 report. "For these reasons, CDC continues to recommend DOT as the standard of care for all persons prescribed TB treatment; however, based on the evidence summary, this report updates the 2016 CDC U.S. clinical practice guidelines (1) to state that vDOT should be considered equivalent to in-person DOT."

In its ruling, the agency said vDOT, which enables care providers to watch patients taking their prescribed medication by video, usually through the patient's smartphone, has seen higher rates of medication adherence compared to in-person monitoring. In addition, the digital health platform is more convenient for patients and providers, can save time and costs for programs, helps patients who can't easily access in-person healthcare and improves patient satisfaction.

The ruling is specific to TB treatment, which can last several months and relies heavily on a patient's ability to take specific medications at specific times.

Among those supporting vDOT is the New York City Department of Health, whose TB control program included vDOT as far back as 2014. The CDC asked the city, which has one of the highest TB rates in the nation (6.1 per 1,000 people, compared to the national average of 2.5) to participate in a study of the value of vDOT, and used the results in its recent ruling supporting the platform.

“Directly observed therapy has been a backbone of our work for a long time and of course the pandemic put a lot of that under threat in restricting people’s movement and their ability to remain adherent on what can be at a minimum 6 months of treatment, if not longer,” New York City Health Commissioner Ashwin Vasan told STAT News in an interview.

“In over 200 patients studied, it was found to be just as effective as traditional DOT, in addition to being more cost-effective because you obviously reduce transportation costs,” he added. “You reduce delays, you reduce trade-offs and opportunity costs because these are visits that can happen over video that would otherwise cause the person to leave work, or leave school, or to leave wherever they are, and present to a clinic to pick up their medications.”

Both the CMS ruling on AppliedVR and the CDC's move to support vDOT give digital health companies hope that the healthcare industry will embrace these new tools and technologies, especially if Medicare, Medicaid, and other payers also support the treatments.

And that's crucial. Many health systems are operating on razor-thin margins and don't have the time or money to invest in new technologies unless there's a clear ROI.

Among the companies benefiting from the CDC announcement is Scene Health, formerly emocha, which offers vDOT services to a number of public health programs across the US for treatment of a wide range of chronic conditions, including substance abuse, asthma, diabetes, and hypertension.

"In recognizing that video DOT is equivalent to in-person DOT, the CDC has modernized the 'gold standard' for medication adherence," Scene Health CEO Sebastian Seiguer, in Nashville for the ViVE conference, said in an e-mail to HealthLeaders.

"DOT is used for all medications in the inpatient setting, but has seen limited use in outpatient care due to high cost and logistical burden," Seiguer said. "Video technology exponentially reduces these barriers making DOT scalable. At the same time, at Scene Health we’ve worked very hard to preserve the person-to-person, supportive engagement that makes DOT work, regardless of delivery method."

In the AppliedVR case, CMS created a unique Healthcare Common Procedure Coding System (HCPCS) Level II code (E1905) for the company's RelieVRx program, which uses virtual reality-based cognitive behavioral therapy. The CMS ruling classifies the technology platform as durable medical equipment (DME).

"It's finally time to more fully embrace ITx [immersive therapeutics] and move toward its use becoming more towards standard of care rather than a 'one off' niche solution in the treatment of chronic lower back pain, for example," Matthew Stoudt, co-founder and CEO of AppliedVR, said in a press release announcing the CMS action.

"We envision immersive therapeutics as a future alternative to a lifetime of pills or costly surgeries," he added. "Enabling broad coverage for the RelieVRx program will deliver a powerful, yet affordable and scalable digital solution for millions of people."