hotspot -WSS

hotspot

author：knowledge 2025-08-11 08:01:25 - browse：5875

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： Malaria cases in Florida and Texas: Here’s what you need to know
Next article： Mike Pence clashes with Tucker Carlson in Iowa

WSS

Lilly’s weekly insulin works as well as daily products, new studies show

Mike Pence clashes with Tucker Carlson in Iowa

Celiac disease study examines precisely how gluten triggers injury

Supreme Court to hear if Covid misinformation is protected speech

Why H5N1 bird flu is keeping the CDC's top flu scientist awake

Adam's Biotech Scorecard: PDS Biotech's survival benefit is overstated

focus

hotspot

hotspot

State Dept. review finds Biden bears some blame for Afghanistan failures

Can CDC director Mandy Cohen drive consensus in Washington?

After affirmative action ruling, medical educators look to 'holistic review'

Can CDC director Mandy Cohen drive consensus in Washington?

Drug repurposing or repositioning? The language matters

Georgia court denies Trump's request to quash DA's 2020 election probe

Drug repurposing or repositioning? The language matters

Congress: Eradicate hepatitis C and reduce the deficit

ChatGPT in medicine: STAT answers readers' burning questions

CVS is willing to dump 10% of its Medicare Advantage members

explore

4 killed in mass shooting in Georgia, shooter remains on the loose: Police

Readout Newsletter: Biogen, Ionis, Johnson & Johnson news

Europe sees delivery challenges ahead on Alzheimer's therapies

To spot an incipient stroke, tiny brain probe acts ‘like a microscope’

Special counsel informs Trump he is target in probe of efforts to overturn 2020 election

Elon Musk says Twitter has 'negative cash flow' and 'heavy debt'

focus

focus

focus

hotspot