leisure time -WSS

leisure time

author：fashion 2025-09-27 12:49:03 - browse：12

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： New air purifier tech could be key to improving indoor air quality
Next article： Sanders adds drug shortage policies to pandemic preparedness bill

knowledge

WSS

FDA sets aggressive timeline for overhauling inspection procedures

Medicare bonuses could stop drug shortages under Senate plan

FDA approves RSV monoclonal antibody for infants, toddlers

Microsoft launches AI tool for clinical documentation through Epic

AI can’t replace a physician’s gut feeling

TikTok, Instagram influencers need more rules for drug ads

explore

leisure time

knowledge

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

AI can’t replace a physician’s gut feeling

Novavax promises a turnaround & Lilly roils the obesity market

Microsoft launches AI tool for clinical documentation through Epic

Duchenne breakthrough therapy leaves behind pioneering families

Medicare to cover more brain scans for Alzheimer’s patients

BioMarin wins approval for gene therapy to treat hemophilia A

Google and Epic fight stronger regulation of AI in health care

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

ARCH Venture Partners tops STAT's 2023 biotech VC rankings

focus

CVS is on a mission to consolidate health care. Will it work?

FDA sets aggressive timeline for overhauling inspection procedures

How Medicaid coverage policies for immigrants impact new moms

Detailed data confirm benefits, risks of Eli Lilly's Alzheimer's drug

Medicare has a new plan to address drug shortages

Listen: Wegovy in the brain & pivotal Alzheimer's data

focus

knowledge

entertainment

hotspot