Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns
This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination (NCD) process, the use of Coverage with Evidence Development, harmonizing with the Food and Drug Administration (FDA), and ensuring patient safety. CMS has conducted its NCD review process for medical devices for many years but in recent years the process has slowed and become less predictable. The operational flaws that exist within the NCD process ultimately could prevent Medicare beneficiaries from accessing innovative technologies, especially at a time when CMS considers assuming new responsibilities for evaluating new technologies.
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News / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs
Bipartisan Health Tech Investment Act Will Enhance Patient Access to AI-Enabled Medical Devices
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WASHINGTON – AdvaMed, the Medtech Association, today commended Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) for introducing the Health Tech Investment Act (S. 1399). This landmark bipartisan legislation will establish a stable reimbursement pathway for medical devices authorized by the U.S. Food & Drug Administration (FDA) that rely on artificial intelligence (AI) and machine learning (ML), also known as Algorithm-Based Healthcare Services (ABHS).
Resource / Coverage & Payment / Executive Orders / Global & Trade / Supply Chain / Tariffs
Amendment To Reciprocal Tariffs and Updated Duties as Applied to Low-Value Imports from The People’s Republic of China
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News / Coverage & Payment / Government & Legislative Affairs / Regulatory Affairs
AdvaMed Congratulates Dr. Oz on his Confirmation as CMS Administrator
April 3, 2025
Washington, D.C.– AdvaMed®, the Medtech Association, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Mehmet Oz to serve as Administrator of the U.S. Centers for Medicare and Medicaid Services.
Blog / Coverage & Payment / Diagnostics / Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Small Business
AdvaMed®’s Medical Innovation Agenda for the 119th Congress
March 28, 2025
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Event / Compliance / Coverage & Payment / Regulatory Affairs
Richardson Waiver Repeal: What it Means for Medtech
Now On Demand
Sidley Austin, joined by HPA, will lead a program examining the impact of HHS repealing the so-called “Richardson Waiver”, including its history, how it could impact the activities of the U.S. Department of Health and Humans Services (HHS), what it all means for medtech and its patients.
Resource / Coverage & Payment / Diagnostics / Global & Trade / Government & Legislative Affairs / Health Equity / Legal / Regulatory Affairs / Small Business
The Medical Innovation Agenda for the 119th Congress
March 13, 2025
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Resource / Coverage & Payment / Executive Orders / Global & Trade / Supply Chain / Tariffs
The Impact of Tariffs on Patient Access to Medical Technology
February 25, 2025
Tariffs on medtech could disrupt supply chains, increase costs, and delay care. Exemptions are needed to protect hospitals, patients, and innovation.
Event / Coverage & Payment
AdvaMed® Payment Policy Forum
May 20, 2025: 8:15 AM – 4:15 PM ET
May 21, 2025: 8:15 AM – 1:00 PM ET
Gain insights from thought leaders and industry experts as they delve into medtech payment policies, private payer challenges and more.