hotspot -WSS

hotspot

author：leisure time 2025-08-11 16:25:07 - browse：35

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： BioMarin wins approval for gene therapy to treat hemophilia A
Next article： 6 solutions to address cancer drug shortages and others

WSS

Stop Congress from blocking public access to science

Maisha Meds is a PBM, but don't call it that

Future doctors need a strong humanities education

Will an HIV vaccine ever be a reality?

Study points to new risk in gene therapy death of Terry Horgan

2023 Nobel Prize in Medicine goes to Karikó and Weissman

hotspot

hotspot

explore

Tori Bowie and the unacceptable rates of Black maternal death

Future doctors need a strong humanities education

Medicare proposal to cover medical devices draws a mixed reaction

Medicare drug price lawsuits could be good politics for Biden

Sports medicine is finally prioritizing gender equality

FDA sees ‘potential systemic bias’ in Amgen’s KRAS drug trial

23andMe had bad news about my health. I wish a person had delivered it

Dog Aging Project founders on what lies ahead after losing funding

Walensky prepares to leave CDC — and Congress — behind

A pediatrician calls for Congress to pass the child tax credit deal

focus

Flu vaccine reformulation won't be easy, manufacturers warn

CRISPR base editing slashes cholesterol levels in monkeys

To bolster infectious disease surveillance, genomics powerhouses team up

What causes osteoarthritis? Researchers study link to brain protein

Study points to new risk in gene therapy death of Terry Horgan

Medicare drug price lawsuits could be good politics for Biden

hotspot

hotspot

leisure time

focus