hotspot -WSS

hotspot

author：entertainment 2025-09-06 03:32:34 - browse：56572

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： In Memoriam: Notable people who died in 2023
Next article： Ohio train derailment: Experts on toxic chemical risks

knowledge

WSS

Ozempic has benefits for kidney disease as well as diabetes

Lack of health data on LGBTQ+ people has serious consequences

Immune cells and nerve overgrowth may explain recurring UTI pain

Neuroscience renaissance leads to new crop of psychiatric drugs

5 ways to address the shortage of health care workers

Medicare isn't yet testing food as medicine

entertainment

hotspot

explore

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Fetal cell organoids grown from amniotic fluid, study finds

Continuity nursing helped my family in our darkest PICU moments

Redefining sustainability for the pharmaceutical industry

What does generative AI mean for health care? We asked experts

There should be a 'Moonshot' or 'Warp Speed' for rare diseases

Duchenne breakthrough therapy leaves behind pioneering families

Pfizer is about to make a big push in cancer. Will investors listen?

In Memoriam: Notable people who died in 2023

Microsoft's Peter Lee: Generative AI could help doctors be more human

focus

Neuroscience renaissance leads to new crop of psychiatric drugs

Change Healthcare cyberattack affects 25% of CVS/Aetna insurance claims

Streamlined flu vaccines recommended by FDA advisory panel

Medicare drug price negotiation hearing pits pharma v Biden admin

Laying a path for careers in science

Study fuels hope CAR

focus

knowledge

leisure time

hotspot