The article focuses on the approval by the Centers for Medicare & Medicaid Services (CMS) on the applicability of the Medicare secondary payer (MSP) statute to clinical trial sponsor payment agreements in the U.S. It notes that proof of responsibility is insufficient for the agreement to pay ...
The revised Medicare payment to hospital outpatient departments for the service will provide better support for healthcare facilities utilizing this ground-breaking technology and should facilitate broader adoption across hospital outpatient settings. This follows the already published approval of a new CMS...
The FDA approval follows clinical research that included a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer's disease (three of whom died during the trial, although it's not clear if the drug played a role), and which showed a 2...
Many stakeholders have emphasized the particular importance of the percentage of patients who screen positive for social needs. The rate itself should not be rewarded or penalized, recognizing that it would be influenced by the community in which a practice exists and its patient population. Yet thi...
anticipated patient enrollment and the expansion of the clinical trial sites; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline...
The CMS national coverage determination for the Alzheimer’s drug Aduhelm may fail to support health equity, as underrepresented populations may have limited access to clinical trial opportunities.
risk is the primary risk under question (this means that initial questions surrounding safety and effectiveness have been resolved), or one in which it is known that the device can be safe because other manufacturers have received FDA premarket approval or clearance for that particul...
Cardiovascular Angiography and Interventions(SCAI), and theAmerican Association for Thoracic Surgery(AATS)—last November, following theFDAapproval of theMitraClip(Abbott Vascular) last October for patients with significant symptomatic mitral regurgitation (MR>3+) who are deemed too high risk for open ...
The European approval comes months after the FDA’s approval of the first-of-its-kind treatment for pulmonary arterial hypertension (PAH). August 22nd 2024 Obesity Uncovered: Dr Eden Miller on US Obesity Epidemic, Insurance Shortcomings Brooke McCormick On this episode of Managed Care Ca...
The FDA granted anaccelerated approvalfor aducanumab in June based on evidence that the drug clears amyloid in the brain. However, it is unclear whether clearing the protein from the brain results in clinical benefit. Usually, accelerated approvals precede the completion of phase 3 drug trials, ...