The Veterans Health Administration is tapping AppliedVR to expand military veterans' access to virtual reality-based therapy for chronic lower back pain.
The VHA, part of the Department of Veterans Affairs, expanded its contract award with the immersive therapy startup to support its FDA-authorized RelieVRx program, a home-based solution for treating chronic pain.
AppliedVR and the VA have been collaborating since 2020 when the two organizations piloted VR-based solutions to comfort veterans in palliative care and help improve the quality of life of veterans experiencing general chronic pain, stress and anxiety in a variety of health care settings.
AppliedVR was awarded the contract through VA Immersive, a division of VHA Office of Healthcare Innovation and Learning (OHIL), that is testing out innovative healthcare technologies like VR and augmented reality (AR) solutions in clinical settings to shift the paradigm in care delivery and experience.
VHA provides care to more than 9 million veterans nationwide.
More than 50% of veterans receiving care at VA facilities suffer from chronic pain. The VHA has stepped up efforts to explore innovative, drug-free approaches to tackle chronic pain among veterans. Addressing mental health issues among veterans, particularly as these issues overlap with chronic pain, is a top priority for the agency. Research has shown that VR can help reduce anxiety. The VA has been using VR for a number of years to treat post-traumatic stress disorder among veterans.
"The VA has been one of the very earliest pioneers in this whole idea of immersive technology as a medicine, dating back to almost 30 years to some to the earlier work in PTSD from an exposure therapy perspective. As they have been using this in multiple forms across the VA, they're recognizing the power of this as a new modality. They've become very focused on how do they try to drive acceptance and adoption across the VA so that becomes a standard of care within the VA system," said Matthew Stoudt, co-founder and CEO of AppliedVR, in an interview with Fierce Healthcare.
AppliedVR inked a contract with the VA back in December 2022 that enables doctors at 18 VA facilities to prescribe the VR-based pain treatment solution to veterans for use in their homes.
AppliedVR's flagship product, the RelieVRx program, was granted marketing authorization by the Food and Drug Administration in 2021 for chronic lower back pain. The program consists of a headset and software guiding patients in pain management exercises.
RelieVRx is the first and only FDA-authorized in-home immersive VR pain treatment indicated as an adjunctive treatment for chronic lower back pain, the company noted.
With the grant funding issued last year, AppliedVR focused on establishing pathways to prescribe VR therapy within the VA population, Stoudt said.
"We burned through that, quite frankly, in about three months, faster than any of us expected, which goes to show the level of demand and acceptance," he said.
The partnership will enable doctors at 16 VA facilities to prescribe the VR-based pain treatment solution to veterans.
"We're using these 16 centers to help to establish the ground rules, if you will, for how do you prescribe the VR for the home. This becomes an accelerant because any VA anywhere in the system, in theory, can write a prescription for our device today because we're on something called the FSS [Department of Veterans Affairs Federal Supply Schedule], that's the formulary, if you will, for the VA," Stoudt said. "This is helping to establish national guidelines and most of the VA centers tend to follow those national guidelines. It becomes an accelerant to getting it into the hands of more veterans."
The company initially offered VR-based therapy in VA clinics but is now focused on providing immersive therapy in veterans' homes.
"We are the first FDA-approved device for home use. If you want to think about accessibility, for too long we forced people to go find healthcare, versus using technologies to bring healthcare to where they are, so we're one of the first devices that they've been working on that is being used in the home," Stoudt noted.
AppliedVR's eight-week program has been clinically demonstrated to decrease pain intensity and pain interference in the lives of people experiencing chronic lower back pain. In a recent clinical trial follow-up study, the RelieVRx program was shown to deliver durable effects up to 24 months after treatment completion.
Through various partnerships and collaborations, the VA has deployed more than 2,200 virtual reality headsets across more than 165 VA medical centers and 18 additional sites of care in all 50 states, according to the VA Immersive website.
VA Immersive's mission to set national standards for leveraging VR will accelerate the adoption of immersive therapeutics across VA, enabling the country's wounded warriors to receive next-generation treatments like RelieVRx, Stoudt said.
"Our experience with the VA is when they find something that is innovative and can help alleviate the challenges that the VA has seen, they want to lean in as much as they can. They are far and away the earliest adopter of this idea of immersive medicine," he said. "We are obviously huge believers in the power of immersive medicine and that this is going to be a standard of care. We have been doing everything we can to embed it into the real systems of American healthcare," he said.
AppliedVR, a Fierce 15 of 2020 honoree, says its virtual reality-based treatments are now used on more than 60,000 patients in 240 hospitals and 1,500 patient homes.
Early on, company leaders recognized the regulatory and reimbursement challenges for prescription digital therapeutics. AppliedVR gained FDA do novo clearance to market its RelieVRx virtual reality system as a hardware-software device combination, Stoudt noted. The company's hardware component proved to be an advantage in its path to FDA approval and to secure Medicare reimbursement, he noted.
Back in March, the Centers for Medicare and Medicaid Services (CMS) granted the company a unique Healthcare Common Procedure Coding System (HCPSC) Level II code for RelieVRx, and placed it in an existing benefit category: durable medical equipment.
AppliedVR now holds the distinction of being the first company to make an immersive therapeutic that is now covered by Medicare, according to Stoudt. The CMS ruling was significant as it paves a reimbursement pathway. Providers can now bill for AppliedVR’s device as durable medical equipment.
Jumping those regulatory and reimbursement hurdles puts AppliedVR in a different category from prescription digital therapeutics, which are often app-based or prescription software, according to Stoudt.
The digital therapeutics market has struggled as Pear Therapeutics, an early pioneer, filed for bankruptcy in April and was sold for parts. Other companies like Akili have struggled to get payers and providers on board with the technology.
"We just took a fundamentally different approach and viewed ourselves as a medical device," he said.
He added, "We're early on in the days of commercialization. One of the biggest challenges that you face in the world of digital medicine is adherence. Our adherence levels have been just crazy high. So we're super excited for that," Stoudt said.