hotspot -WSS

hotspot

author：explore 2025-08-11 07:59:23 - browse：4

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： The cancer drug shortage isn’t new — and neither are the solutions
Next article： Analysis of telehealth claims data suggest service duplication

WSS

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

WuXi Biologics execs register to lobby as Congress comes for the company

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

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

VC firm General Catalyst wants to buy a health system

Colorectal cancer study finds potential in overlooked immune cell

knowledge

hotspot

entertainment

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

STAT series 'Denied by AI' wins major journalism prizes

Trump demands the U.S. pay no more for drugs than other countries … again

ALS treatment from Biogen, Ionis fails in study

Virginia high school admissions case could be legal follow

Physician executives need more than on

Hepatitis C has a cure — but many Americans still lack access to it

Histogen: Failed biotech offers rare public look inside

New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

WuXi Biologics beefs up its lobbying operation

focus

Bill would stop addiction treatment from triggering child abuse inquiry

Oak Street deal isn't the answer to health care's woes

Readout Newsletter: Biogen, Ionis, Johnson & Johnson news

FDA panel signals lack of confidence in Amgen cancer drug data

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

ALS treatment from Biogen, Ionis fails in study

focus

focus

focus

hotspot