Statement attributable to: Octavia Peck Palmer, PhD President, Association for Diagnostics & Laboratory Medicine (formerly AACC)

“Today, we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) provided Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee with input on potential reforms to clinical test regulation. We commend Congress’ efforts to learn more about this vital topic, which has a direct impact on patient care, and we agree that Congress should evaluate and update the underlying statutes that govern the regulatory processes for these tests. Specifically, ADLM supports modernizing the Clinical Laboratory Improvement Amendments (CLIA), through which the Centers for Medicare & Medicaid Services (CMS) regulates laboratory developed tests.

“Senator Cassidy put out a request for information on this topic in response to recent efforts by the Food and Drug Administration (FDA) to unilaterally pursue regulatory reforms through rulemaking that go beyond the agency’s statutory authority and that would give FDA oversight of laboratory developed tests. However, laboratory developed tests are already subject to rigorous oversight under CLIA. Additional FDA oversight would be duplicative, costly — and could force many clinical labs to stop performing these essential tests.

“As an alternative, ADLM suggests updating CLIA’s standards through the Clinical Laboratory Improvement Advisory Committee (CLIAC). This advisory panel is comprised of a wide variety of stakeholders and therefore serves as a good venue for discussing changes to the current laboratory standards.

“ADLM still believes — as it did in November 2021 when our organization joined in a letter to CLIAC with 17 other groups including the American Medical Association and Children’s Hospital Association — that this is the appropriate venue in which to take up concerns about regulation of laboratory developed tests. This is a topic of the utmost public importance and should be discussed by the experts that know the issue best and can address any concerns.

“Once changes are made through the regulatory process, ADLM proposes that Congress evaluate and update the underlying statute that governs CLIA. It has been nearly 40 years since legislators passed the historic legislation to safeguard patient testing.

“Overall, we believe that any changes to laboratory developed test regulation must ensure the accuracy of testing, while also encouraging the innovation and continuous improvements that are crucial to providing timely, quality patient care. ADLM looks forward to working with Congress to achieve these goals.”

To speak to Dr. Peck Palmer about this issue, please contact Molly Polen, ADLM Senior Director of Communications & PR, at [email protected] or 202-420-7612.

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.