Local Coverage With Evidence Development Is Legit, CMS Says; But It May Be Rare
CMS issued its final guidance on the coverage-with-evidence-development program, two years following a draft. It is explicit that local Medicare contractors can employ CED in setting coverage policies in their jurisdictions, but it is not clear that the language will encourage significant use at the local level. The guidance also revises its approach on ending CED policies compared to what was stated in the 2012 draft guidance.
Medicare administrative contractors can incorporate coverage-with-evidence-development policies into local coverage determinations, CMS affirmed in a Nov. 20 final guidance on the CED program.
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.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
