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 The guidance also revises its approach on ending CED policies compared to what was stated in the 2012 draft guidance.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.
Launching a medical device in Japan requires a solid reimbursement strategy as patients can't pay out of pocket. Companies must build ties with experts and prepare a comprehensive reimbursement dossier. Japan's strict pricing and focus on clinical benefits make early planning essential for success.
APACMed 2025 delegates heard how two global device regulators have shifted to a policy of early advice for innovators, with benefits for all industry stakeholders.
The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.
The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.
