By Joe Hoppe

 

Renalytix PLC said Tuesday that plans to scrap a coverage pathway for Medicare beneficiaries to access FDA-cleared or approved breakthrough devices in the U.S. won't likely materially affect business plans for its technology.

The diagnostics group said that following a previously disclosed delay to implementing the final rule establishing the Medicare Coverage of Innovative Technology, or MCIT pathway, the final rule has been proposed to be repealed before Dec. 15.

The Centers for Medicare and Medicaid Services said that it believes there were other ways to provide innovation and access to important new technologies.

The company said on March 15 that the MCIT rule, based on an executive order issued in October 2019, will provide four-year national Medicare coverage for technologies that the Food and Drug Administration recognizes as breakthrough devices, accelerating their rollout. The company's lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019 and submitted its final FDA application in August 2020.

"Given our trajectory for accumulating real-world utility evidence, however, we do not believe there will be a material impact on the KidneyIntelX business plan and are confident of continuing success to secure comprehensive government and private insurance reimbursement for KidneyIntelX," Chief Executive James McCullough said.

 

Write to Joe Hoppe at joseph.hoppe@wsj.com

 

(END) Dow Jones Newswires

September 14, 2021 13:57 ET (17:57 GMT)

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