One of AACC’s signature policy priorities, children’s health, got a boost of support from Congress in July when the House of Representatives included report language in its fiscal year (FY) 2022 funding bill encouraging the Centers for Disease Control and Prevention (CDC) to initiate efforts to improve the accuracy of pediatric reference intervals (PRIs). The association previously secured report language in the FY 2020 budget agreement requesting that CDC submit a plan to Congress for improving PRIs.
AACC’s efforts to educate policymakers about the importance of improving PRIs continues to receive increasing traction in both Congress and the healthcare community. Prominent healthcare groups such as the American Academy of Pediatrics have joined the association’s growing coalition to advocate for the issue. These groups support the CDC’s proposed approach to improving PRIs and have joined AACC in urging Congress to provide the additional funding needed to improve them and ensure equitable, quality care for children in the U.S.
AACC has taken a wholistic approach to building long-term support for this issue. In addition to getting support from the healthcare community, the association has conducted grassroots campaigns and congressional briefings to educate legislative staff. Members of AACC’s Policy & External Affairs Core Committee and the Board of Directors have been invaluable in helping educate policymakers through virtual and in-person meetings with legislators and their staff on Capitol Hill.
CDC already has the infrastructure in place to improve PRIs. The agency has stated that with $10 million annually, it could use its National Health and Nutrition Examination Survey (NHANES) to obtain the needed clinical data and specimens, and the agency’s Environmental Health Laboratory (EHL), which has previously developed reference intervals, could potentially conduct the studies and disseminate the information to clinical laboratories. AACC is currently working with its allies to secure funding for this initiative in the FY 2022 budget.
In other good news for AACC’s work on children’s health, the Newborn Screening Saves Lives Reauthorization Act of 2021 passed the House of Representatives with strong bipartisan support. The legislation, which AACC endorsed, reauthorizes federal newborn screening programs for another 5 years and provides funding for states to expand their programs. It also ensures the quality and accuracy of testing and aids efforts to educate parents on the treatment and care of children. In addition, the bill renews the Advisory Committee on Heritable Disorders in Newborns and Children under the Health Resources and Services Administration. AACC is working with its allies to push for passage of this critical legislation in the Senate.
AACC is also looking to secure funding for CDC to expand harmonization efforts in the budget. Taking the same approach to build support for PRIs, AACC has been leading a coalition that has resulted in legislators providing $2 million every fiscal year since 2018. Although the COVID-19 pandemic absorbed much of Congress’s attention and made visiting legislator’s offices more difficult, the association and other allied organizations continue to advocate for greater funding and are seeking to expand that appropriation in the next fiscal year.
AACC Mobilizing Support to Protect Patient Access to Lab Developed Tests
The regulation of laboratory developed tests (LDTs) continues to be a foremost priority in AACC’s advocacy agenda, as the debate over whether the Food & Drug Administration (FDA) should oversee them continues to play out with the healthcare community and Congress. The association’s Policy & External Affairs Core Committee has been essential in contributing to AACC’s efforts to educate policymakers about LDTs. Over the summer, members met virtually with legislative offices to raise awareness about the impact this issue would have on the ability of their organizations to conduct cutting edge testing for the patient populations they serve. The association also produced a virtual congressional briefing earlier this year for congressional staff on Capitol Hill, describing the importance of LDTs in diagnosing COVID-19.
This debate was reignited during the early days of the pandemic with competing legislative proposals introduced in Congress. Similar bills have been reintroduced this year, including The Verifying Accurate Leading-edge IVCT Development (VALID) Act in the House and Senate by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO), and Sens. Richard Burr (R-NC) and Michael Bennet (D-CO). If passed, the VALID Act would eliminate the current pre-market approval and 510(k) processes regulating in vitro diagnostic (IVD) test kits and replace it with a new process for all laboratory tests–including LDTs–under a proposed, newly defined regulatory category of in vitro clinical tests overseen by the FDA. The legislative counterpoint to the VALID Act is the Verified Innovative Testing in American Laboratories (VITAL) Act, introduced by Sen. Rand Paul, which would codify the existing regulatory structure under the Clinical Laboratory Improvement Amendments (CLIA).
There is much confusion in the media and among policymakers about LDTs. One mischaracterization is that these tests are unregulated. In truth, LDTs are stringently regulated by the Centers for Medicare and Medicaid Services (CMS) under CLIA, and laboratory directors must ensure these tests are scientifically valid or face severe sanctions. When asked to assess the quality of LDTs, the FDA took 2 years to find 20 examples of tests that might be problematic, many of which were disproven.
AACC supports streamlining the FDA review process for IVD manufacturers; however, it strongly objects to extending FDA oversight to LDTs. While increases in the number and complexity of LDTs may warrant regulatory review, AACC believes the regulation of LDTs should be discussed and acted upon within the Clinical Laboratory Improvement Advisory Committee (CLIAC), the federal advisory body that guides CMS on changes to the CLIA standards. This issue promises to remain a top priority for the association throughout 2021 and into the next year.
As the leading voice for laboratory medicine professionals, AACC advocates strongly for policies that improve patient care through laboratory medicine. The association continues to remain engaged in legislative debates affecting the clinical laboratory community. By participating in grassroots advocacy, AACC members amplify the organization’s voice and facilitate success in the policy arena.
More information about current initiatives and how to get involved can be found on www.aacc.org, under the Advocacy & Outreach tab.