- Finalization to the Medicare Coverage of Innovative Technology (“MCIT”) rule from CMS will benefit Renalytix (RNLX +3.9%), Exact Sciences (EXAS +3.7%), and Bio-Techne Corporation (TECH -0.6%), Stifel says in an industry update.
- Proposed in August, the new rule expects to cover devices with FDA breakthrough designation on the date of their respective market authorization leading to a four-year coverage thereafter.
- These devices have typically received Medicare coverage via National Coverage Decisions (“NCD”) or Local Coverage Decisions (“LCD”), a process that could take a year to finalize.
- While waiting for more details with the final ruling, the analysts attempt to identify the significant beneficiaries.
- With the breakthrough status, Renalytix’s KidneyIntelX platform is awaiting FDA approval. Exact's liver test and EPI test from Bio-Techne (NASDAQ:TECH) have breakthrough status and yet to file for FDA approval.
- See the table below for a comparison of the three stocks.