A virtual reality company that invented a device that offers what it calls an immersive experience that helps patients battling chronic lower back pain said it hopes the government’s approval of the product will perhaps entice commercial health plans, self-insured employers and other payers to take a closer look.
The Centers for Medicare & Medicaid Services (CMS) labeled the product, RelieVRx, a durable medical device. AppliedVR, the manufacturer, now holds the distinction of being the first company to make an immersive therapeutic to be included in an existing benefit category. And because Medicare now covers the platform, other payers may follow suit.
Matthew Stoudt, AppliedVR’s co-founder and CEO, told Fierce Healthcare he wants payers to know that “we are building an unparalleled body of data that demonstrates both the efficacy of what we’re doing as well as the value of what we’re creating here for the patients. Because we believe fundamentally that that’s ultimately how you’re going to get all the different payers on board.”
According to the CMS determination letter (PDF) approving RelieVRx, patients should use the device at home over an eight-week course of treatment that relies on cognitive behavioral therapy including modules on pain education, breathing practices, pain distraction and mindfulness. The letter said clinical trials demonstrated “statistically greater improvements in pain outcomes from use of the RelieVRx, with immersive VR, as compared to non-immersive interventions” because the device activates “five regions of the brain and [engages] multiple neural systems.”
Stoudt said CMS approval should encourage a greater acceptance of immersive therapeutics as part of standard care—rather than being seen as niche treatment—as they provide an alternative to painkillers and surgeries. He notes that the FDA first had to approve RelieVRx for chronic lower back pain before CMS could approve it as well.
Chronic pain costs the U.S. about $635 billion a year, and the National Institute on Drug Abuse considers it to be a major driver of the U.S. opioid crisis.
“We’re providing a more integrated pain management tool for patients to teach them the skills to be able to start to control the pain on their own,” said Stoudt. “And teaching them the skills is where you’re going to create that long-term impact for patients.”
One of the problems in pain management is that providers often treat chronic pain the same way they’ll treat acute pain. Stoudt said that the amount of pain somebody experiences depends on the person. Some people have a high threshold of pain and some have a low threshold, for example.
A patient’s complaints about pain should never be discounted and they should never be told that it’s in their mind, he said.
“In the early iterations of our company we probably helped deliver more than 150 babies using VR,” he said. “And no one will ever say the pain of delivering a child is in your brain. It’s incredibly painful. And yet we had a lot of success in helping women go through labor and delivery.”
He hopes payers will note the cost-saving capability of virtual reality therapies, as well.
“If you're going to make an impact in healthcare in America, you need to be able to get the solution into the hands of the patients where they are,” said Stoudt. “And a lot of times that’s not in the hospital or in the clinic. We think that’s an outdated paradigm of forcing patients to go into these different places to get their care.”
That makes for a much better experience not only for the patient but for the doctor as well, he said.
“Because now the doctor can actually deliver some things that he or she couldn’t before because they didn’t have a pain psychologist on staff,” he said.