Advocacy - Lab Advocate
On April 26, AACC’s Government Relations Committee (GRC) met with key congressional staff to advocate on behalf of the Association’s key policy initiatives for 2016. Among the GRC members on Capitol Hill were: James Nichols, PhD, GRC Chair; Sharon Ehrmeyer, PhD; Roland Valdes, PhD; Steve Master, MD, PhD; and Neil Greenberg, PhD. The group met with nearly a dozen legislative offices, including Senate Majority Leader Mitch McConnell’s office as well as the office of Senator Chuck Schumer, a member of the Democratic leadership. The GRC focused on two issues that are relevant for the current appropriations cycle—harmonization of clinical laboratory test results and Food and Drug Administration (FDA) oversight of laboratory developed tests (LDTs).
The AACC delegation learned that there is widespread support among Republican and Democratic offices for harmonizing clinical laboratory test results. In 2014, AACC’s congressional champions succeeded in getting report language in an end-of-the-year funding bill, which directed the Centers for Disease Control and Prevention (CDC) to work with the private sector in harmonizing test results. Since then the Association has been working with CDC and with appropriations staff to lay the groundwork for an appropriations request to support the CDC standardization program. AACC and its Capitol Hill consultants are working closely with House appropriators to get expanded language included in the Labor, Health and Human Services, Education, and Related Agencies Appropriations bill to support appropriations. Early indications are that such language will be included in the bill, and AACC is hopeful that Congress will provide funding as well.
LDTs remain a hot-button issue on Capitol Hill. Conversations during the April 26 Hill visits revealed that offices on both sides of the aisle recognize the complexity of the issue. As Lab Advocate has reported, recent actions in both the House and Senate reflect the concerns among many legislators about greater FDA involvement in this area and questions about the FDA’s use of guidance in lieu of the normal rulemaking process. Some legislators, however, favor a greater FDA role. AACC has urged that any changes to LDT oversight be made in the context of CLIA rather than through new FDA requirements. The Association has developed and circulated on Capitol Hill its recent position statement ‘Modernizing CLIA’ that identifies ways to enhance LDT oversight under CLIA to address some of the concerns raised by proponents of FDA oversight. The GRC and AACC will continue to engage policymakers on issues of importance to the Association and clinical laboratory community.