CMS Establishes Reimbursement Pathway for Virtual Reality Program

For the first time, the Centers for Medicare and Medicaid Services (CMS) has established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code for a virtual reality program.

The code categorizes the RelieVRx program, the flagship product of virtual reality therapeutics provider AppliedVR, as durable medical equipment (DME). This makes it the first digital therapeutic to be placed in an existing benefit category, according to the press release.

In 2021, the RelieVRx program, formally known as EaseVRx, became 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 comprised of two levels. Level I consists of Current Procedural Terminology (CPT-4) codes maintained by the American Medical Association. 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.

Further, 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."

The establishment of the code creates a more definitive pathway for the solution to secure Medicare coverage eligibility. Though CMS has not made a final payment determination for RelieVRx — noting that payment determination will be addressed at an upcoming HCPCS public meeting — securing Medicare coverage could help the program gain more comprehensive coverage through commercial payers. 

"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," said Matthew Stoudt, co-founder and CEO of AppliedVR, in the press release. "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. Earlier this month, Massachusetts General Hospital 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.

Similarly, the University of Maryland School of Medicine announced last May that it is 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.