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
FDA approves 1st 2-drug HIV treatment
Ella Jeffries / beckershospitalreview - The FDA has approved Merck’s once-daily, two-drug regimen for adults with virologically suppressed HIV-1. The treatment combines 100 mg doravirine and 0.25 mg islatravir and is indicated for patients with no history of virologic treatment failure and no k…
AI Summary: The FDA has approved Merck’s once‑daily two‑drug antiretroviral regimen, marking a notable market entrant poised to compete with established single‑pill therapies. Regulators cleared the novel combination on efficacy and safety data, setting up potential shifts in prescribing, pricing and competition — and giving Gilead something new to grumble about.