Hello Rapid Response Subscriber,

This is week 4 of rapid response updates! As part of our effort to keep you in the loop, you’ll be getting an email update from us each week covering both emerging policy issues impacting industry and responsive AdvaMed activity. 

We welcome your insights and questions on any of the topics included. Please don’t hesitate to reply directly or raise additional concerns through the submission portal on our Emerging Policy Response Center. We also encourage you to share with your colleagues! 

In Case You Missed It: 

Scott delivered our industry’s message before the Senate Finance Committee on May 14th —an important moment for AdvaMed and the MedTech community. 

• Watch, like, and share highlights from Scott’s testimony on our YouTube channel.
• Engage with and amplify AdvaMed’s LinkedIn post and Scott’s post. Leave a comment, repost, and spread the word.
• Do the same on Twitter/X to extend our reach even further.

Every click helps our message resonate further—thank you for being part of it!

Issue 1: Supreme Court Review of Kennedy v. Braidwood Management, Inc.  

What’s Happening:

On April 21, 2025, the U.S. Supreme Court heard oral arguments in Kennedy v. Braidwood Management, Inc., a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) under the Affordable Care Act (ACA). The plaintiffs argue that the USPSTF's recommendations, which mandate insurance coverage for preventive services, are unconstitutional due to the Task Force's appointment process. Following the arguments, the Court ordered additional briefing to address whether the Secretary of Health and Human Services has the power to appoint USPSTF members, a central issue in the case. 

Why It Matters:

The court’s decision could affect coverage requirements for various medical services, diagnostics, and devices, potentially leading to structural changes in healthcare coverage. 

What’s Next & AdvaMed Action:

AdvaMed worked with outside legal counsel to prepare an executive overview of this case that is located on the Emerging Policy Response Center. 

The Supreme Court is expected to issue its decision in the next few months. AdvaMed is closely monitoring the case and will update members once a decision is issued, including hosting a member webinar. 

Issue 2: Executive Orders on Federal Procurement Reform 

Notable New Activity: 
AdvaMed met with the Coalition for Common Sense Government Procurement to better understand the process for implementing the EO, discuss how to engage most effectively, and how we can collaborate as things move forward. We continue to request member feedback on this EO and potential engagement in an AdvaMed member-only ad hoc discussion group.

What’s Happening:

President Trump issued two Executive Orders aimed at overhauling the federal procurement process: 

• Restoring Common Sense to Federal Procurement:
  Directs a major reform of the Federal Acquisition Regulation (FAR), eliminating non-essential provisions to improve efficiency, reduce costs, and promote usability. It includes a regulatory sunset clause for non-statutory rules, which will expire after four years unless renewed.
• Ensuring Commercial, Cost-Effective Solutions in Federal Contracts:
  Prioritizes the use of commercially available products and services in federal contracts to promote innovation and reduce reliance on costly, custom solutions.

Why It Matters:

These changes could lower barriers for MedTech companies seeking to do business with the federal government, opening more opportunities for commercial technologies and streamlining compliance burdens. 

What’s Next & AdvaMed Action:

AdvaMed continues to review the impact of these reforms and monitoring forthcoming implementation guidance from OMB and the FAR Council. AdvaMed met with the Coalition for Common Sense Government Procurement to better understand the process for implementing the EO, discuss how to engage most effectively, and how we can collaborate as things move forward.

Share your insights: rapidresponse@advamed.org.

Issue 3: Executive Order on Most-Favored-Nation Drug Pricing 

What’s Happening:

President Trump signed an Executive Order directing federal agencies to pursue policies that align U.S. prescription drug prices with those paid in other developed countries. The order instructs HHS to establish mechanisms allowing patients to access most-favored-nation (MFN) pricing directly and directs the U.S. Trade Representative and Commerce Secretary to address international pricing practices. 

Why It Matters:

This action seeks to reduce domestic drug costs and shift pricing strategy in global pharmaceutical markets.

What’s Next & AdvaMed Action:

AdvaMed is monitoring implementation and any related rulemaking. 

Other RFIs/Comments We Are Tracking

To ensure alignment and efficiency, AdvaMed will continue to coordinate responses across teams and ensure consistency across related RFIs.

The Office of Management and Budget (OMB) has issued a Request for Information seeking public input on outdated, unnecessary, or burdensome federal regulations as part of a broader deregulatory initiative. This effort provides a platform for the MedTech industry to identify regulatory barriers that hinder innovation or patient care. AdvaMed has solicited member input across policy teams and divisions and has officially submitted comments. Access the submission here.

The U.S. Department of Health and Human Services (HHS), in coordination with the FDA, has issued a Request for Information (RFI) seeking public input on regulations that should be modified or eliminated across all HHS agencies. The initiative supports the administration’s 10-to-1 deregulatory policy and broader efforts to reduce regulatory burdens on providers and the healthcare system. The public comment portal is now open, and responses will be accepted for 60 days.

The Department of Justice (DOJ) has launched an Anticompetitive Regulations Task Force and issued a Request for Information (Docket No. ATR-2025-0001), seeking public input on laws and regulations that may hinder competition. In addition, the DOJ and Federal Trade Commission (FTC) issued a joint letter directing federal agencies to identify regulations that reduce competition, entrepreneurship, and innovation. Comments are due by May 26.

The Centers for Medicare & Medicaid Services (CMS) has issued a Request for Information on Medicare Regulatory Relief, inviting input on policies that may create unnecessary burdens or limit access to care. The comment deadline is June 10.