hotspot -WSS

hotspot

author：comprehensive 2025-08-25 07:19:01 - browse：94

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： Wildfire smoke exposes gaps in outdoor worker protections
Next article： The Affordable Care Act has saved billions in health care costs

WSS

Humana’s losses in Medicare Advantage tank its stock

Divers poised to search for children washed away in Pennsylvania flash flood

10 reasons why health care startups fail

Vir antibody drug aimed at influenza A fails in clinical trial

Ending racial health disparities hinges on penalties, political will

Syphilis numbers in the United States reach record heights

focus

hotspot

focus

The high cost of giving birth even with insurance

DeSantis talks Trump, trans issues and 'what wokeness is'

Dobbs anniversary: the lost opportunity of abortion as health care

Merck, Johnson & Johnson CEOs will testify on high drug prices

Wildfire smoke exposes gaps in outdoor worker protections

DeSantis talks Trump, trans issues and 'what wokeness is'

New air purifier tech could be key to improving indoor air quality

Stanford president's case begs question: Who takes blame?

ChatGPT in medicine: STAT answers readers' burning questions

DeSantis talks Trump, trans issues and 'what wokeness is'

focus

Tocagen's brain cancer gene therapy trial continues. Investors worry

FTC sues over Novant Health acquisition of two N.C. hospitals

Philips to halt sales of sleep apnea machines in U.S.

Stanford president faces new allegations over 1999 paper

Study identifies new proteins linked to dementia risk 25 years later

New clues to why women have higher risk of autoimmune disorders

focus

Wikipedia

Wikipedia

Wikipedia