ARTICLE SUMMARY:
CMS addresses new medical technology in its FY 2023 hospital Inpatient Prospective Payment System final rule. Excerpted from Pathways' Picks August 3: Medicare and Medtech, EU Picks, and More.
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. 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.
Bonus payments. Also in the IPPS final rule: Six new medical devices were selected for new technology add-on payments (NTAPs) starting October 1, including five that qualified for the bonus payments via the streamlined pathway open to FDA-designated Breakthrough Devices:
- Hemolung RAS for acute hypercapnic respiratory failure, ALung Technologies Inc. ($6,500)
- Cerament G forosteomyelitis (Breakthrough), Bonesupport AB ($4,918.55)
- GORE TAG Thoracic Branch Endoprosthesis for aortic aneurysm/transection/dissection (Breakthrough), W.L Gore and Associates Inc. ($27,807)
- iFuse Bedrock Granite Implant System for spinal fusion (Breakthrough), SI-BONE Inc. ($9,828)
- Thoraflex Hybrid Device for aortic aneurysm/dissection (Breakthrough), Terumo Aortic ($22,750)
- ViviStim Paired VNS System for stroke rehabilitation (Breakthrough), MicroTransponder Inc. ($23,400)
CMS also awarded NTAPs to two drugs, and retained existing NTAPs for six devices and nine drugs. And it is discontinuing add-on payments for 24 devices and drugs, including 13 that had received a one-year extension on the payments due to the COVID-19 emergency.
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