Under 2015 legislation, CMS is intensely focused on tying payments to quality of care for patients seeing specialists such as gastroenterologists and cardiologists. But because the primary focus of alternative payment plans is on short-term patient outcomes, things like device durability or other long-term impacts from innovation won't easily be rewarded, a Medicare agency official told device-makers May 5.
It's going to be challenging for CMS to measure the quality that innovative devices provide as the Medicare agency moves to adapt physician-focused alternative payment models required by the 2015 Medicare Access and CHIP Reduction Act (MACRA), a CMS official told device-makers May 5.
"We want to be able to incentivize and provide rewards for people involved in true improvement activities … but there...
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
