explore -WSS

explore

author：focus 2025-10-02 18:48:22 - browse：241

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： Walmart eyes Medicare Advantage provider ChenMed

WSS

FDA proposes changes to key medical devices approval pathway

FDA approves updated Covid vaccines

Regeneron agrees to White House price limits on anti

Readers discuss the intersection of pregnancy and addiction

Pharma companies must ensure equitable access to obesity drugs

FDA reviewers ask if approval of Lilly’s Alzheimer’s drug should be restricted

Wikipedia

explore

focus

United colonoscopy coverage change 'may cost lives,' doctors say

Heat wave can put hearts into ‘oxygen debt,' lab experiment shows

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Generate Biomedicines machine learning biotech raises $273M

BioMarin wins approval for gene therapy to treat hemophilia A

Popular nasal decongestant doesn't actually relieve congestion

Virginia high school admissions case could be legal follow

Study: Why relieving medical debt did not improve financial outcomes

Medical records are filled with copy

Report captures long Covid’s disabling effects and policy challenges

hotspot

Acelyrin, a rare IPO success, stumbles in its first big test

Hospitals consider fixing cancer drug shortages on their own

Private equity could exacerbate cardiology's overuse problem, experts fear

Deposition: Sackler embraced plan to conceal OxyContin’s strength

White House touts steps to stem shortages of cancer treatments

Generate Biomedicines machine learning biotech raises $273M

hotspot

hotspot

knowledge

hotspot