Why It Matters

AdvaMed lobbying directly targets policies likely to reshape device market access and reimbursement:

Congressional momentum appears favorable. Recent House Energy and Commerce hearings expressed bipartisan frustration with CMS delays post-FDA approval. Members like Rep. Blake Moore and Rep. Lori Trahan are actively championing breakthrough device access legislation, signaling strong political will for the industry’s core priorities.

By the Numbers

The Advanced Medical Technology Association (AdvaMed) filed a Q3 2025 in-house lobbying disclosure reporting $860,000 in quarterly expenditures.

AdvaMed has maintained a hybrid lobbying model since at least 2003, filing 534 total disclosures over two decades with combined spending exceeding $83 million. The organization’s primary strategy relies on in-house advocacy: 77 in-house disclosures from 2003-2025 totaled $67.2 million, representing the vast majority of its spending.

This internal capacity is supplemented by external firms including Tarplin, Downs & Young LLC, BGR Government Affairs LLC, Kountoupes Denham Carr & Reid LLC, Alpine Group Inc., CGCN Group LLC, and Mehlman Consulting Inc. for specialized expertise on FDA regulation, Medicare policy, and environmental compliance.

The Agenda

Advanced Medical Technology Association (AdvaMed) is lobbying on core medical device industry priorities with specific focus areas:

The medical device industry faces a pivotal moment balancing significant challenges with meaningful opportunities.

Congress is actively advancing legislation to address the "valley of death"—the prolonged gap between FDA approval and Medicare coverage for breakthrough devices. The House Energy and Commerce Health Subcommittee held hearings in January 2025 examining policies to enhance seniors’ access to breakthrough medical technologies, signaling bipartisan frustration with current coverage delays. Multiple pieces of legislation are advancing, including H.R. 4441 to provide conditional Medicare payment for breakthrough devices and bills modernizing reimbursement for digital therapeutics and AI-enabled health services.

However, tariffs pose a significant near-term threat. The administration’s sweeping tariffs on imports directly affect the industry, with hospitals potentially facing 15% cost increases on medical supplies.

AdvaMed’s Q1 and Q2 2025 filings show active engagement on Section 301 tariffs and supply chain issues, reflecting acute concern over import duties affecting device manufacturing and pricing.

Regulatory relief on ethylene oxide sterilization standards offers some reprieve. The administration extended compliance deadlines by two years, reducing immediate compliance burdens on manufacturers—an issue AdvaMed has consistently tracked through external lobbying firms.

Between The Lines

Congress is actively advancing a slate of initiatives directly aligned with the medical device industry’s core priorities. H.R. 4441 – Patient Access to Innovative New Technologies Act of 2025 enjoys strong bipartisan support, aiming to expedite Medicare coverage for FDA-approved breakthrough devices—addressing the persistent "valley of death" between regulatory approval and reimbursement. The House Energy and Commerce Health Subcommittee held a January 2025 hearing focused specifically on accelerating seniors’ access to breakthrough technologies, with members expressing bipartisan frustration at CMS delays.

Beyond breakthrough devices, Congress is modernizing reimbursement frameworks for emerging technologies. The Access to Prescription Digital Therapeutics Act of 2025 and S.1399 – Health Tech Investment Act would establish Medicare and Medicaid pathways for FDA-approved digital therapeutics and AI-enabled healthcare services. Regulatory modernization efforts include the Medical Device Electronic Labeling Act and the Medical Device Nonvisual Accessibility Act of 2025, reflecting congressional interest in reducing compliance costs while expanding device accessibility.

A bipartisan coalition is championing these initiatives. Rep. Blake Moore (R-UT) and Rep. Lori Trahan (D-MA) are leading breakthrough device access efforts, while Senators Alex Padilla (D-CA) and Todd Young (R-IN) introduced companion Senate legislation. The House Veterans’ Affairs Committee held a January 2025 hearing on modernizing VA device acquisition processes, highlighting bureaucratic barriers to new technology deployment.

Competitive Landscape

The medical device industry presents a multilayered lobbying environment where AdvaMed operates alongside other major industry players with overlapping advocacy priorities. The Medical Device Manufacturers Association (MDMA) represents smaller, innovative companies and consistently lobbies on FDA approval processes, market access barriers, and sterilization standards. Medline Industries Inc. focuses heavily on supply chain resilience, Section 301 tariffs, and sterilization—issues that AdvaMed also tracks in its recent filings.
This collective advocacy demonstrates clear industry consensus on core priorities:

  • Breakthrough device access: Multiple organizations champion streamlined Medicare coverage pathways for FDA-approved innovations
  • Digital and AI reimbursement: Coordinated efforts to establish payment frameworks for software-based treatments and algorithm-enabled services
  • Regulatory modernization: Unified support for electronic labeling standards and accessibility requirements
  • Supply chain protection: Shared concern over tariffs, Section 301 duties, and sterilization regulations

The Bottom Line

AdvaMed’s substantial in-house lobbying operation and strategic use of external firms position it as the industry’s primary voice, but the broader medtech sector’s aligned priorities amplify the collective message on Capitol Hill and create reinforcing pressure for legislative and regulatory action.