Centers for Medicare & Medicaid Services Issues First Hcpcs Code and Medicare Dme Benefit Category Determination for Therapeutic Virtual Reality Device

• Jurisdiction: United States,Federal
• Citation: Vol. 1 No. 4
• Publication year: 2023

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Deborah Samenow, Rachel Ludwig, Christine Lentz, and Kristi Kung ^*

In this article, the authors explain why a recent determination by the Centers for Medicare & Medicaid Services amounts to a significant first step in pursuing Medicare coverage and reimbursement for virtual reality therapies.

In a recent trailblazing coding and benefit category determination, ¹ the Centers for Medicare & Medicaid Services (CMS) has established a unique Healthcare Common Procedure Coding System (HCPCS) Level II code for a virtual reality (VR) device and associated software, RelieVRx.

CMS also issued a final benefit category determination for RelieVRx under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) benefit category. This is the first VR therapeutic device to receive a HCPCS code and DMEPOS benefit category determination.

The Device

On March 3, 2021, AppliedVR Inc. was granted Food and Drug Administration (FDA) breakthrough status for the first FDA-authorized immersive VR medical device for home use indicated for the treatment of chronic low back pain, RelieVRx. This Class II medical device, available only pursuant to a prescription, consists of a modified proprietary headset (not available for retail sale) as

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well as a patented breathing amplifier that allows integration of bio-enabled immersive experiences, and preloaded software.

As CMS explains, the device delivers a clinically based multi-modal pain self-management program that incorporates evidence-based principles of cognitive behavioral therapy (CBT) and other neuroscience-based behavioral health methods to reduce pain intensity and pain interference with daily activities, sleep, mood, and stress for patients diagnosed with moderate to severe chronic low back pain. RelieVRx therapy is administered daily as a three- to 16-minute module over the course of 56 days. It is intended to be used during an eight-week treatment program in the patient's home and involves a sequential set of immersive experiences with a mix of different components used in CBT, including pain education, diaphragmatic breathing practices, pain distraction, interceptive awareness, and mindfulness escapes. The device is locked such that it can only be used for treatment of the specified clinical indication.

Citing the applicant's assertions, CMS noted that the clinical trial evidence demonstrates that the durable VR hardware is required to deliver significantly greater reductions in pain...