We’re pleased to share AdvaMed®’s first-ever MedTech Reimbursement Playbook! This course will review market access opportunities for novel technologies, explore private payer challenges, and ensure you’re able to drive positive coverage, coding and reimbursement outcomes within your organization.
With a one-time purchase you’ll have full access to this incredible resource that will leave you confident in your knowledge of the “three-legged stool” of payment—coding, coverage, and reimbursement. Sign up to receive the Playbook today!
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News / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Health Access / Regulatory Affairs
AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
August 20, 2025
WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.
News / Diagnostics / Digital Health / Government & Legislative Affairs / Medical Imaging / Regulatory Affairs
AdvaMed Welcomes MDUFA VI Discussion Kickoff at FDA Public Meeting
August 4, 2025
WASHINGTON, D.C.—AdvaMed, the medtech association, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next agreement, MDUFA VI, delivers strong results for the American public.
Event / Digital Health / Regulatory Affairs
AdvaMed® Cybersecurity Summit
November 13, 2025
Join cyber experts for the Cybersecurity Summit that will address the latest industry issues and changes related to FDA requirements.
Blog / Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Tariffs
Medtech is Essential: Industry Supports Call for Tariff Flexibility
May 29, 2025
AdvaMed President and CEO Scott Whitaker testified before the U.S. Senate Finance Committee, bringing attention to the pressing issue of how tariffs could impact the medtech industry and, most importantly, the patients who depend on it.
Blog / Government & Legislative Affairs / Regulatory Affairs
Orthogonal, Kwame Ulmer on the Value of AdvaMed Membership
May 20, 2025
At AdvaMed, we’re proud to be recognized for our work on behalf of the medtech community – and we’re especially grateful when that recognition comes from respected voices like Kwame Ulmer of MedTech Impact Partners and our colleagues at Orthogonal.
News / Diagnostics / Digital Health / Government & Legislative Affairs / Regulatory Affairs
AdvaMed Releases “AI Policy Roadmap” to Guide Congress and Federal Agencies
April 22, 2025
Washington, D.C.—AdvaMed, the Medtech Association, today released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the next era of artificial intelligence-enabled medical and digital health technologies to provide patients and clinicians transformative new tools to aid in diagnosis and treatment.
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.
Resource / Regulatory Affairs
Medical Device Submissions Guidebook: 510(k) & De Novo
April 2, 2025
This in-depth 510(k) & De Novo Guidebook will provide real-world case studies, tips and best practices directly from FDA and industry experts.