Piomic receives Medicare Category B Designation for MAVERICKS clinical trial
CMS has approved the COMS One device for Category B designation and for Medicare coverage purposes during Piomic's IDE study
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A significant milestone has been reached in the United States regarding MAVERICKS, the COMS® One therapy system pivotal study in patients with therapy-refractory diabetic foot ulcers (DFUs).
On June 20, 2023 the Centers for Medicare & Medicaid Services (CMS) determined that our COMS device, along with associated and standard items and services, has been approved for Medicare coverage purposes during Piomic’s IDE study – Category B.
Since CMS has approved our study for coverage across all Medicare Administrative regions, study sites will no longer require separate approval from local Medicare Administrative Contractors (MACs). This will enable all Piomic study sites, regardless of their location in the US, to immediately recruit Medicare patients upon site activation.
Doran Edwards, MD, former Medical Director for the Palmetto GBA Pricing, Data Analysis and Coding (PDAC) contract, and COO of Advanced Healthcare Consulting, stated, “CMS’ positive coverage decision for Medicare patients enrolled in Piomic’s IDE study is significant. It will allow study sites to enroll Medicare patients more quickly and in potentially greater numbers, while also generating valuable clinical evidence from the Medicare population. Beneficiary-specific evidence of safety and effectiveness is prioritized by CMS – and is traditionally required – when making coding, coverage and payment decisions for new technologies.”
Chronic, non-healing wounds present a significant challenge for caregivers and patients, and they have profound economic implications for healthcare systems. Through our development of the innovative and user-friendly COMS therapy system, Piomic aims to streamline the complex care delivery system for chronic wound patients in all care settings.