In this week’s roundup: CMS addresses new medtech in its inpatient payment rule; AdvaMed wants action on a novel tech coverage pathway; a new notified body and more EU MDR and IVDR updates; EPA eyes EtO; Medicare Advantage input sought; 3D-printing oversight, and updates from Brazil and Eurasia.
New medtech policies, payments:
New tech liaisons. CMS formalized its “new technology liaisons” program Aug. 1 in the FY 2023 hospital Inpatient Prospective Payment System (IPPS) final rule. “In order to streamline engagement by centralizing the different innovation pathways within CMS including new technology add-on payments, CMS has established a team of new technology liaisons that can serve as an initial resource for interested parties,” the rule states. The liaisons have their roots in a pilot program initiated by CMS in 2020 to help medtech developers, in particular start-ups, to navigate coverage, coding, and payment processes for technologies lacking well-worn reimbursement pathways. (See “CMS Restructures: New Office, Pilot Target Medtech,” Market Pathways, October 9, 2020.) The rule provides an email (MedicareInnovation@cms.hhs.gov) as a primary point of contact to request resources and coordination between various offices within CMS. The agency is also in the process of implementing the Medicare Electronic Application Request Information System (MEARIS) as a streamlined electronic intake system for new technology add-on payments, inpatient procedure category (MS-DRG) classification change requests, and ICD-10-PCS procedure code requests.