Chronic pain has a substantial economic impact on the United States, costing an

estimated $635 billion annually. While VR has been studied and used in various

acute and chronic pain conditions for decades, headset technology has only

recently become simple to use and broadly accessible, and it continues to improve.

AppliedVR, a California-based company pioneering immersive virtual reality for

medical therapeutic use, has achieved a remarkable feat, working with the Centers

for Medicare & Medicaid Services (CMS) to include RelieVRx® in the existing benefit

category for durable medical equipment (DME), the first immersive VR therapeutic

to follow this strategy to tap into existing payment authority.

 

Home-based VR therapies like RelieVRx® hold the potential to broaden access

to effective and on-demand nonpharmacologic treatments for chronic lower

back pain that are durable well beyond the end of treatment. Understanding

reimbursement as a combination of coding, coverage, and payment provides the

context for the hurdles all new technologies must clear. Regulatory strategy may

be underappreciated in terms of its influence on reimbursement success, and this

was certainly key to the decisions related to code assignment and granting the

benefit category as DME for RelieVRx®.

 

Understanding the intricacies of reimbursement codes and benefit categories is

crucial for innovators seeking to navigate the evolving landscape of virtual reality

in healthcare. It is essential to keep an eye on emerging trends and codes to make

informed decisions and leverage opportunities for reimbursement in this rapidly

evolving field. Founders of VR healthcare companies should vigilantly monitor the

evolving reimbursement landscape and how changes may influence their business

model. By capitalizing on these established reimbursement options and staying

attuned to emerging trends, healthcare providers can harness the full potential

of VR technology in delivering innovative and effective treatments.

The importance of integrating real-world evidence (RWE) into the evidence gathering process for determining the placement of new medical technologies on the market cannot be underestimated. RWE derived from real-world data (RWD) can offer more reliable evidence than traditional evidence generation models, leading to improved patient outcomes, greater access, and faster delivery.

MedTech companies often will generate evidence for one specific purpose at a time, such as waiting for regulatory approval before initiating an outcomes-based study.  While this has served the industry well to satisfy regulatory requirements, it has had the unintended consequence of delaying evidence planning for reimbursement.

Instead, adopting an early and integrated approach across all departments can help optimize evidence generation.  A successful comprehensive strategy will provide decision makers with evidence that is delivered earlier, through more efficient and representative studies, and is better tailored to the payer, provider, and patient.

To facilitate this process, the Medical Device Innovation Consortium has created a comprehensive guide for MedTech companies. It assists in embedding RWE throughout their organization and establishing an enterprise-wide RWE strategy. This strategy drives innovation, expands payer coverage, and increases patient access.

 

This resource guide includes the following topics and more:

• The role of RWE in technology innovation
• The value of real-world evidence in medical innovation
• Assessing long-term outcomes and expanded indications
• Increasing the development and use of RWE for medical devices
• Best practices for developing and assessing the quality of RWD and RWE
• Incorporating RWE in future strategies