The Alliance for Regenerative Medicine Applauds New Rule From the Centers for Medicare & Medicaid Services Promoting Access to Innovative Therapies
September 2, 2020
The Alliance for Regenerative Medicine (ARM) applauds the Centers for Medicare and Medicaid Services’ (CMS) decision to finalize a new diagnosis-related group (DRG) for chimeric antigen receptor T cell (CAR-T) therapies in their FY21 Inpatient Prospective Payment System (IPPS) rule. This is a crucial step forward for patient access to life-changing therapies, and the result of multi-year collaboration among ARM, its members, regulators, and a diverse group of other stakeholders.
FDA's Peter Marks Reiterates the Agency's Continued Commitment to Gene Therapy in Meeting With ARM's Executive Committee
August 27, 2020
In a videoconference Thursday with the Executive Committee of the Alliance for Regenerative Medicine (ARM), the FDA’s Dr. Peter Marks reiterated the agency’s continued commitment to gene therapy, and explained that there have been no changes to FDA’s policies or approaches to gene therapies. The FDA remains focused on safety and efficacy in its evaluations of potentially transformative cell and gene therapies.