Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns

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.  

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. 

AdvaMed, the Medtech Association, called on Medicare in a letter sent Friday to cover supplemental imaging for women with heterogeneously and extremely dense breast tissue, noting the life-saving value of the additional screening and the pressing health equity needs Medicare coverage of these critical services would address.   

AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS).

This week, AdvaMed, the Medtech Association, hosted an Artificial Intelligence (AI) Demonstration Day event on Capitol Hill showcasing AI-enabled medical devices and technologies from leading health care companies. The event was honorarily co-hosted by Senators Martin Heinrich (D-NM) and Mike Rounds (R-SD), co-chairs of the Senate AI Caucus.

Today, the Centers for Medicare and Medicaid Services (CMS) issued the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule for CY25, which includes significant wins for patients, including separate payments for diagnostic radiopharmaceuticals, which improves access and ensures better treatment and care. Also of note, CMS’s proposed rule includes coverage for CT Colonography, or virtual colonoscopy, an important tool in detecting colorectal cancer.

The House Ways and Means Committee voted to pass the bipartisan H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act, during a markup meeting.