Dive Brief:
- Digital therapeutics company AppliedVR has been granted a code by the Centers for Medicare and Medicaid Services that will allow its virtual reality-based back pain treatment to be covered as durable medical equipment.
- AppliedVR’s lead product, RelieVRx, uses a virtual reality headset with built-in software, including mindfulness exercises and education, to help people with chronic lower back pain.
- The approval could open the way for other VR devices that take a similar approach.
Dive Insight:
Digital therapeutics, devices where software is used as a treatment, have managed to gain clearance from the Food and Drug Administration, but insurance coverage has remained a challenge. Some companies have sought for their software-based treatments to be covered through patients’ pharmacy benefits, but AppliedVR is taking a different approach.
CMS granted the company a new HCPCS (Healthcare Common Procedure Coding System) code, defining its treatment as a virtual reality cognitive behavioral therapy device that includes pre-programmed therapy software. The program met CMS’ five requirements to be categorized as durable medical equipment.
“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 wrote in its determination letter.
AppliedVR received FDA clearance in 2021 for its first product to reduce lower back pain, and hopes to expand to additional conditions in the future. Now, the company is in the process of running a 1,000-person health economics and outcomes research study, the results of which could also help persuade insurers to cover the device.
Since CMS gave it the code, AppliedVR will now work with the agency to establish the payment rate as it prepares for a broader market launch in the U.S., the company said in a statement.
