Phillip A Coleman El

A new US pathway aimed to align approval and insurance review for breakthrough medical devices, cutting potential coverage waits to ~2 mo from >1 yr.
The program covered breakthrough technologies addressing unmet medical needs, moving insurance review earlier in development while those devices already received faster federal approval.
Officials said the pathway still had to clear rulemaking, including ~2 mo of public comment, before implementation could begin.
Examples included artificial heart valves, heart-rhythm devices, and nerve-stimulating implants used to treat disease.
Federal officials said 40 devices were already eligible, with another 20 potentially joining the program.

US Device Coverage Could Speed Sharply

After Congress let ACA subsidies expire in Late-Q4, tens of millions saw health insurance premiums jump overnight, many to >2x their previous rate.
A survey found 66% of Americans worried about affording health care for themselves and family, ranking it above food, utilities, gas, and housing.
Overall living costs also weighed heavily: 82% said costs ↑ over the past yr, and 50% said those increases were substantial.
Health care led budget worries. While 32% were very worried about medical costs, only 24% said the same about food and groceries.
More than half, 55%, said health care costs ↑ over the past yr. Another 56% expected care to become less affordable as current year progressed.