The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and to modernize healthcare systems so that patients benefit from durable, potentially curative treatments.
As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations.
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (the “Proposed Rule”).
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Rule on Ensuring Access to Medicaid Services (the “Proposed Rule”).
ARM applauds ICER for addressing needed updates regarding patient engagement, clinical trial diversity, and real-world evidence priorities; however, ARM raises critical concerns with ICERs approach for assessing the value of cell and gene therapies, particularly as is relates to timing of their assessments and considerations around health benefit price benchmarks.
ARM appreciates this opportunity to comment on the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program proposed rule (the “Proposed Rule”).
ARM asks the chair of the House Committee on Energy Commerce to support policies that ensure patients with healthcare coverage through state Medicaid programs can access emerging cell and gene therapies (CGTs).
ARM offers the following comments detailing the challenges of the New Technology Add-on Program (NTAP).
ARM thanks Representatives Anna Eshoo and Brett Guthrie for their leadership championing policies to ensure patients can benefit from durable, potentially curative cell and gene therapies.
ARM is grateful to Senators Grassley and Bennet, and Representatives Trahan and Miller Meeks for their leadership championing policies to ensure children with medically complex conditions enrolled in Medicaid can access specialized care across state lines.
Comments
The Alliance for Regenerative Medicine (ARM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed payment updates to the fiscal year 2024 Hospital Inpatient Prospective Payment System (Proposed Rule).