Medicare’s New Codes For Remdesivir, Convalescent Plasma To Be Test Of Real-World, Though Not Real-Time, Data
CMS’s new procedure reimbursement codes will help generate ‘critical information’ on the effectiveness of the COVID products, but will suffer from a ‘claims lag.’
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Hahn’s communications, which go far beyond the claims a sponsor could make of an investigational product, are raising new concerns about the agency’s ability to serve as a science-based regulator during the coronavirus pandemic. HHS Secretary Alex Azar and NIAID Director Anthony Fauci have also touted the lifesaving nature of plasma donations for COVID-19, even though the treatment is still unproven.
Gilead’s COVID treatment will be the first product tracked in a system that could eventually help allocate vaccines and other therapeutics.
Bipartisan congressional letters seek relief from HHS but the Trump Administration has taken aim at 340B providers itself and may not be inclined to help.