The Centers for Medicare and Medicaid Services (CMS) has created a Healthcare Common Procedure Coding System (HCPCS) Level II code for the RelieVRx program, the first virtual reality-based digital therapeutic for pain relief to gain FDA approval. The code categorizes RelieVRx as durable medical equipment, making it the first digital therapeutic to be placed in an existing benefit category. This new code creates a more definitive pathway for RelieVRx to secure Medicare coverage eligibility, potentially allowing it to gain comprehensive coverage through commercial payers.
The Centers for Medicare and Medicaid Services (CMS) has established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code for the RelieVRx program, the flagship product of virtual reality therapeutics provider AppliedVR. This marks the first time that a virtual reality program has been categorized as durable medical equipment (DME) and placed in an existing benefit category. The establishment of this code creates a more definitive pathway for the RelieVRx program to secure Medicare coverage eligibility, which could also help the program gain more comprehensive coverage through commercial payers.
The RelieVRx program, formerly known as EaseVRx, is the first virtual reality-based digital therapeutic for pain relief to gain Food and Drug Administration approval. The program provides participants with a virtual reality headset preloaded with software content. It guides chronic low back pain patients through an eight-week program that teaches cognitive behavioral skills and other pain relief methods.
The HCPCS is made up of two levels: Level I consists of Current Procedural Terminology (CPT-4) codes maintained by the American Medical Association, while Level II includes codes used primarily to identify products, supplies, and services not included in CPT-4, such as DME. To be categorized as DME, the RelieVRx program had to meet five requirements, including withstanding repeated use and not being useful for individuals without an illness or injury.
Furthermore, CMS noted that it considers the solution to be one device. “For the RelieVRx, the medical software and the device on which it is housed are so integral to each other that we consider them to be one whole device, not software and a separate device,” CMS stated in its determination letter. “We consider RelieVRx to be one whole device for a few reasons, including because the software is locked to the device. In addition, the software cannot be used on any personal devices and no other non-medical software can be added to the device.”
Matthew Stoudt, co-founder and CEO of AppliedVR, sees the establishment of the code as an opportunity to move towards immersive therapeutics becoming more of a standard of care than a niche solution. Stoudt stated, “We envision Immersive Therapeutics as a future alternative to a lifetime of pills or costly surgeries. Enabling broad coverage for the RelieVRx program will deliver a powerful, yet affordable and scalable digital solution for millions of people.”
The use of virtual reality solutions in healthcare is growing. Massachusetts General Hospital recently partnered with Rocket VR Health (RVH) to conduct a randomized controlled trial to assess the efficacy of a virtual reality digital therapeutic. The solution purports to improve quality of life, address symptom burden, prevent distress, and support self-efficacy among blood cancer patients.
The University of Maryland School of Medicine is also partnering with researchers, computer scientists, and physician-scientists from the University of Maryland College Park and the University of Michigan to create the Center for Medical Innovations in Extended Reality. The center’s goal is to advance the use of virtual reality in patient care by developing, testing, and certifying new technologies.
Virtual reality technologies are part of a broader trend sweeping the healthcare industry: the rise of digital therapeutics. Defined by the Digital Therapeutics Alliance as evidence-based, clinically evaluated software and devices that can treat an array of diseases and disorders, digital therapeutics are currently being applied to address chronic pain, diabetes, behavioral health issues, and substance use disorders.