JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...

CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices

The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class ...
Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Health Affairs

Medicare “Coverage With Evidence Development” Leaps Into The Spotlight With CMS Draft National Coverage Decision On Alzheimer’s Drugs

The Centers for Medicare & Medicaid Services (CMS) issued a ground-breaking draft national coverage decision (NCD) on January 11, 2022, for Food & Drug Administration (FDA) approved monoclonal ...
JD Supra

CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development

Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost ...
Health Affairs

Medicare ‘Coverage With Evidence Development’ For Aducanumab? How Might It Work?

In the wake of the Food and Drug Administration’s (FDA’s) controversial decision to approve aducanumab for Alzheimer’s disease, how will, and how should, Medicare respond? We propose a coverage with ...
Forbes

Aduhelm’s Paltry $1 Million In Q4 Sales Indicates CMS’s Coverage With Evidence Development May Be Biogen’s Only Chance At Salvaging Something From The Product

Last month, the Centers for Medicare and Medicaid (CMS) released a draft memorandum regarding its national coverage determination of the class of monoclonal antibodies directed at beta-amyloid plaque ...