CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

fiercehealthcare - The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement. CMS said it will pause the existing TCET pathway.

AI Summary: CMS and the Food and Drug Administration launched a coordinated program to accelerate Medicare coverage for breakthrough medical devices, aiming to shorten the gap between regulatory approval and patient access. The initiative aligns agency review processes, defines eligibility, and seeks faster coverage decisions while maintaining safety and evidentiary standards.

• New imaging and monitoring devices promise faster, remote patient care. (3)
• On scene: agencies align to speed device approvals and coverage. (6)

New imaging and monitoring devices promise faster, remote patient care.

On scene: agencies align to speed device approvals and coverage.

Flagging first-quarter volumes dragged CHS’ earnings

Sydney Halleman / healthcaredive - Executives said consumer fears and aggressive denials from payers fueled declining volumes in the quarter, which led CHS to a $58 million loss. Still, the hospital operator said it expects volumes to pick up in the back half of the year.

AI Summary: Community Health Systems reported first-quarter earnings pressured by a steep drop in patient volumes, blaming a surge in payer preauthorization denials for the decline. Executives say the volume shortfall materially weighed on revenue and margins, underscoring how administrative friction between providers and payers can quickly translate into financial pain for hospital operators.

• CHS Q1: earnings hit by volume drops, blame on payers (4)
• Hospitals fight denials: startups, RCM shifts and C-suite focus (4)
• Medicare AI prior authorization pilot causing care delays (3)
• Payers move to standardize prior auth; Congress weighs in (4)
• All Other Stories

CHS Q1: earnings hit by volume drops, blame on payers

Hospitals fight denials: startups, RCM shifts and C-suite focus

Medicare AI prior authorization pilot causing care delays

Payers move to standardize prior auth; Congress weighs in

All Other Stories

Gene therapy improves hearing in 90% of patients with inherited deafness in largest trial of its kind

livescience - A new gene therapy tested in China has improved the hearing of 38 people who were born deaf due to mutations in a gene called OTOF.

AI Summary: A gene therapy for inherited deafness delivered dramatic results, restoring hearing in roughly 90% of treated patients in the largest trial of its kind. Investigators report durable improvements over follow-up, signaling a potential one-time intervention for certain genetic deafness types and challenging the notion that auditory loss is always irreversible. Hope, meet hard data.

• FDA approves first-ever gene therapy for inherited hearing loss (6)
• Primate study finds human-like genetic cause of blindness (1)
• Trial shows durable hearing restored in most patients (3)

FDA approves first-ever gene therapy for inherited hearing loss

Primate study finds human-like genetic cause of blindness

Trial shows durable hearing restored in most patients