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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Blog / Coverage & Payment / Diagnostics / Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Small Business
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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 / Tariff
The Impact of Tariffs on Patient Access to Medical Technology
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Tariffs on medtech could disrupt supply chains, increase costs, and delay care. Exemptions are needed to protect hospitals, patients, and innovation.
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News / Coverage & Payment / Government & Legislative Affairs
AdvaMed® Welcomes Bipartisan Senate Bill to Expedite Medicare Coverage of Breakthrough Medical Technologies, Diagnostic Tests
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AdvaMed®, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-“breakthrough”-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June.
News / Coverage & Payment
AdvaMed®: Final CMS Payment Rules Contain Significant Victories for Patients
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AdvaMed®, the Medtech Association, today said two new final payment rules from the Centers for Medicare and Medicaid Services (CMS) for 2025 contain several important provisions that will improve access to care and improve outcomes for millions of Medicare beneficiaries. The measures include longstanding priorities for patient groups, providers, and medtech innovators.