At-Home Dialysis System Gets Landmark Medicare Designation
Outset’s at-home dialysis system is the first technology approved for Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES), a designation created for US Medicare kidney patients.
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Proposed ESRD Reimbursement Changes Look To Improve Equity In Care For Patients With Chronic Kidney Disease
Changes to the mandatory payment model now used by the US Centers for Medicare & Medicaid Services (CMS) for kidney disease would encourage facilities to provide treatment to lower income patients.
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.