ACLA’s 2025 Annual Meeting provided a day of political and policy insights from leading public and private sector experts to the more than 200 attendees that included representatives from member clinical laboratories, associate member diagnostics manufacturers, and patient organizations. ACLA congratulates the ACLA Board of Directors for the 2025-2027 term, elected by the ACLA membership during the meeting.
ACLA Board Chair and President & CEO of Mayo Collaborative Services William Morice, II, MD PhD and ACLA President Susan Van Meter kicked off the meeting with an overview of ACLA’s 2025 advocacy agenda emphasizing the top legislative priority of securing long-term PAMA reform while highlighting the association’s core mission to develop and advance policy to expand patient access to innovative clinical laboratory services so patients can live healthier, longer lives.
Senior health advisors for Senate Finance Committee Chairman Mike Crapo (R-ID) and Ranking Member Ron Wyden (D-OR), Conor Sheehy and Marissa Salemme, respectively, joined ACLA Vice President of Government Affairs and Policy Mary Lee Watts and ACLA advisor, Mark Rayder, Partner, Alston & Bird, for a dynamic discussion on the outlook for the new Congress operating in a challenging fiscal environment.
Mr. Sheehy and Ms. Salemme emphasized the bipartisan support for securing long-term PAMA reform, appreciating ACLA’s work with the Committee to advance common sense reform. The discussion included consideration of prior authorization reform, correct coding, expansion of Medicare coverage for screening tests, among other topics. Finally, the panel noted the connection between clinical laboratory testing services, which inform 70% of medical decisions, and the developing “Make America Healthy Again” platform as clinical laboratory tests empower patients and their doctors to ascertain a patient’s health status, prevent, detect, and manage disease in an increasingly personalized manner.
Mike Allen, co-founder of Axios, with Susan Van Meter, offered an animated discussion of the political environment, offering commentary and insights on the President’s priorities, activities of the DOGE, the Administration’s engagement with the GOP-led House and Senate, including analysis of the Senate confirmation process for Administration nominees. Mr. Allen offered recommendations for maximizing the effectiveness of communication in complex times, urging an embrace of “Smart Brevity.”
Further, meeting attendees took in an “off the record,” discussion and analysis of the Trump Administration’s actions to date from two health care policy experts and veterans of the first Trump Administration, Anna Abram, Senior Advisor, Akin and Jane Lucas, Partner, Alston & Bird, moderated by Susan Van Meter.
ACLA’s regulatory counsel, Scott Danzis, Partner, Covington & Burling, moderated a discussion with regulatory and legal experts on how clinical laboratories and key regulators are preparing for the May 6 compliance date for Stage 1 of the FDA’s final rule that regulates laboratory developed testing services as medical devices under the Food, Drug and Cosmetics Act, at the same time ACLA is challenging the rule in court. The panel included Beverly Rauch, Director, Clinical Laboratory Evaluation Program, Wadsworth Center in New York State, Jonathan Genzen, Chief Medical Officer, ARUP Laboratories, and Ashley Parrish, Partner, King & Spalding. Panelists, noting existing federal and state regulation of laboratory developed testing services, expressed concern for innovation and patient access to critical testing under FDA’s rule. Mr. Parrish, earlier this month represented ACLA in oral arguments before the US District Court for the Eastern District of Texas on ACLA v. FDA. He noted the strength of ACLA’s position that the statute is clear that laboratory developed testing services, which are professional services, are not medical devices. ACLA requested the court issue a decision prior to the May 6 compliance date and will continue to work with the Administration and Congress on this important issue.
ACLA’s Chief of Advocacy Operations Elyse Oveson and public affairs consultant Kirsten Thistle delved into ACLA’s value campaign, the Power of Knowing, sharing ACLA’s newest ads and video content featuring ACLA members. Joined by patient advocacy group partners Nikki Martin, Senior Director, Precision Medicine Initiative LUNGevity Foundation, and Rebecca Edelmayer, Vice President, Scientific Engagement, Alzheimer’s Association®, the panel highlighted the critical role of communicating the importance of clinical laboratory innovations in saving patient lives.
A panel of public and private payers discussed processes for assessing and developing coverage policies for innovative tests during a session featuring Barb Liwosz, Director of Laboratory and Precision Medicine for Blue Cross Blue Shield Association (BCBSA); Mark Esposito, M.D., Medical Director for the Maryland Department of Health; and Gabriel Bien-Willner, M.D., Ph.D., CMO with Palmetto GBA/MolDx.
The lively conversation included Maryland Medicaid’s plans for implementation of biomarker testing coverage, MolDx’s role and expansion of the DEX system, and insights on how the BCBSA provides guidance to local Blues managing state-mandated coverage policies. The session also addressed the impact of prior authorization and how laboratories can support the implementation of coverage policies moving forward. The panel was moderated by ACLA’s Senior Director of Reimbursement Policy, Sarah Thibault-Sennett and Senior Director of Government Affairs, Holly Grosholz.
