hotspot -WSS

hotspot

author：entertainment 2025-08-12 11:29:22 - browse：26

Adobe

The medical device industry is split on whether a proposed new Medicare reimbursement pathway will do anything to soothe their insurance coverage woes.

Device makers have long complained that the unclear, rocky road to payment kills innovative companies. So they were thrilled when the Trump administration proposed a rule that would have guaranteed four years of Medicare coverage of approved devices deemed “breakthroughs” by the Food and Drug Administration. They hoped private payers would follow suit. But in 2021, under a new administration and a push for more device scrutiny, the Centers for Medicare and Medicaid pulled back on the idea, promising a replacement that would streamline coverage for innovative devices while ensuring safe, high-quality care.

The pathway put forth last week, called Transitional Coverage for Emerging Technologies (TCET), is only a notice, not yet a rule that would grant CMS new powers. The program applies solely to devices that have earned a place in the FDA’s breakthrough device program, which was established to identify devices that the agency believed could provide “more effective” treatment or diagnosis of serious conditions than the current standard of care. But because those devices can be brought to market with less certainty in their benefits and risks than other products, experts said, the idea of automatic reimbursement was dicey.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED Log In

Previous article： document.writeln('关注创业、电商、站长，扫描A5创业网微信二维码，定期抽大奖。
Next article： Why a market frenzy over new weight loss drugs defies logic

explore

WSS

ProMED, early warning system on disease outbreaks, in peril

STAT Summit: Meghan O’Rourke on making chronic illness visible

OTC birth control: A brief history of over the counter pill design

White House drug shortage group privately met with industry

OTC birth control: A brief history of over the counter pill design

Cassava Sciences’ Alzheimer’s clinical trials should be halted

explore

hotspot

hotspot

DIEP, the 'gold standard' of breast reconstruction, is under threat

For BCIs, commercial hurdles may be bigger than scientific ones

In age of alternative facts, a scholarly course on calling out crap

Readout LOUD podcast: Live from the 2023 STAT Summit

Malaria cases in Florida and Texas: Here’s what you need to know

Wild otter attack leads to woman being airlifted to hospital, 2 others treated for injuries

DIEP, the 'gold standard' of breast reconstruction, is under threat

Why a market frenzy over new weight loss drugs defies logic

DIEP, the 'gold standard' of breast reconstruction, is under threat

Roivant's CEO is a star, but biotech's black hole persists

entertainment

STAT Readout: Friday, Oct. 20 biotech updates

My superpower is killing ticks

Dramatically reducing cancer deaths requires the PASTEUR Act

Mega Millions jackpot rises to record $1.55 billion for Tuesday's drawing

Mega Millions jackpot rises to record $1.55 billion for Tuesday's drawing

The future of Biogen: Pragmatism, ‘moonshots,’ and no Twinkies

explore

Wikipedia

hotspot

entertainment