CMS: PainShield Not Covered by Medicare, Medicaid

The same week NanoVibronix announced it had extended its distribution agreement with Ultra Pain products, the company also received the disappointing news that the Centers for Medicare and Medicaid Services (CMS) decided its PainShield Surface Acoustic Wave (SAW) portable ultrasonic therapeutic device did not fall within the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies benefit category.

The decision was part of the publication of CMS’s Aug. 21 Healthcare Common Procedure Coding System (HCPCS) Application Summaries, Coding Decisions, and Benefit Category & Payment Determinations for the first bi-annual 2023 Non-Drug and Non-Biological Items and Services.

CMS’ decision means that the PainShield device is not currently reimbursable under Medicare and Medicaid. The company said they plan to address CMS concerns and resubmit an application for additional review.

In a statement addressing CMS’s decision, Brain Murphy, CEO of NanoVibronix, said, “We are working to fully understand the implications of CMS’ HCPCS summaries and payment determinations as it relates to PainShield. Over the coming weeks, we will be developing an action plan to address CMS’ concerns and, at the very least, resubmit an application for additional review. We are exploring several options with our legal and technical teams.”

“We continue to believe that PainShield provides an effective therapy for pain management and could greatly benefit many of the more than 150 million patients covered by Medicare and Medicaid insurance,” he continued. “Despite our disappointment with the recent decision from CMS, we continue to grow the distribution of PainShield in the workers’ compensation, personal injury and Veterans’ Administration spaces.”