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STAT+: CMS proposes rolling back breakthrough device payment flexibilities
The Centers for Medicare and Medicaid Services is proposing to repeal a pathway that currently allows breakthrough devices to qualify for supplementary payments without proving they provide a substantial clinical improvement over alternatives.
Access to lifesaving new technologies can be stymied when hospitals don’t get paid enough to cover their costs. So since 2001, Medicare has given innovative devices a chance at extra payments when they meet three criteria: they’re new and different from what’s currently available, they offer a clinical improvement over existing options, and they’re especially costly.
Since 2021, devices that receive breakthrough designation from the Food and Drug and Administration have gotten an even sweeter deal: In order to qualify for the extra payments, they only have to demonstrate they’re expensive.
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Amgen shores up Tavneos’ FDA defense with Duke data analysis
Amgen shores up Tavneos’ FDA defense with Duke data analysis
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval. Read More
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Chile offers new data on food warning label efficacy
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So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.
The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.
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Meet Superman’s grandfather in new trailer for Krypton
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Amgen shores up Tavneos’ FDA defense with Duke data analysis
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Novartis’ $12B Avidity buy pays dividends with Phase 1/2 muscular dystrophy win
STAT+: At hospital finance conference, a call to end the friction that’s keeping costs high
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Laser‑Driven Phase Contrast Enhances Cryo‑EM Resolution of Small Proteins
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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