Pathways’ Picks May 6: Spotlight on Medicare, Serology, Workarounds, and EU

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ARTICLE SUMMARY:

A roundup of what’s coming out of the US Centers for Medicare & Medicaid Services leads off this week’s Pathways’ Picks. Also: the latest on serology test oversight, FDA workarounds, EU notified body data and more.

Reps. Diana DeGette, D-CO, and Fred Upton, R-MI, who led the charge on the 2016-enacted 21st Century Cures Act, are trying to push forward with a follow-up “Cures 2.0” bill. The House members recently pushed out a 12-page concept paper last week, seeking feedback on top priorities for the prospective legislation, including one issue of high concern to the device industry: modernizing CMS coverage and payment programs, particularly for breakthrough therapies. A look at that and other US reimbursement news, as well as updates from FDA, the EU, and more in the latest Pathways’ picks.

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