explore -WSS

explore

author：comprehensive 2025-09-04 04:25:18 - browse：9476

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： Continuity nursing helped my family in our darkest PICU moments
Next article： Indictment alleges Trump's ex

WSS

Dozens dead from Maui wildfires: What we know about the victims

Is mRNA technology the right fit for flu shots? Experts aren’t so sure

Surge in Apellis stock fueled by confidence in safety of its eye drug

UnitedHealth has 90,000 doctors — 10% of all physicians in U.S.

Health AI: on the border between health care and tech

What to know about the judge who will handle the Trump case

focus

explore

explore

Peter Hotez and the public health issue of online harassment

Despite FDA concern, risk that CAR

The cancer drug shortage isn’t new — and neither are the solutions

Pediatric cancer treatments threatened by a new FDA policy

Affirmative action in medical school literally saved lives

Rep. Raul Ruiz on the physician shortage and more

At least 13 dead in Texas as scorching temps continue

Illinois Supreme Court finds assault weapons ban constitutional

Affirmative action in medical school literally saved lives

After Optum profits sink, UnitedHealth makes changes

knowledge

BMS, looking to build heart drug business, turns to AI for diagnosis

ReNAgade cuts staff seven months after raising $300 million

The EPA's new lead rule: How one expert crunched the numbers

After Optum profits sink, UnitedHealth makes changes

Biden administration begins canceling student loan debt for 804,000 borrowers

Disappointing trial forces Pfizer to pivot on obesity medicine plans

focus

focus

hotspot

focus