hotspot -WSS

hotspot

author：knowledge 2025-10-01 23:39:47 - browse：71

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： Apple is now the first public company to be valued at $3 trillion
Next article： Physicians and social media: If you see something, say something?

explore

WSS

Readout Newsletter: Parkinson's study, Gilead, CG Oncology

Physicians and social media: If you see something, say something?

Gene editing the human germline: What are the risks?

FDA sets aggressive timeline for overhauling inspection procedures

FDA sets aggressive timeline for overhauling inspection procedures

Inaction leaves children at risk from dangerous chemotherapy drug

focus

hotspot

focus

Supreme Court strikes down use of affirmative action

The inclusion problem at the heart of rehabilitation research

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

Positive childhood experiences can help future health

Tori Bowie and the unacceptable rates of Black maternal death

Methadone treatment changes are coming. Do they go far enough?

Activists slam private health insurers over coverage restrictions

Microsoft launches AI tool for clinical documentation through Epic

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

Creating egg and sperm cells from stem cells raises ethical issues

explore

Microsoft launches AI tool for clinical documentation through Epic

Baby aspirin cuts fat buildup in liver disease patients, in small study

FDA endorses new sterilization method for medical devices

Neuroscience’s long legacy of racism

Plastic surgeons increase patient psychiatric screenings

Stop the failed accountable care organization experiment

knowledge

explore

hotspot

focus