Advocacy - Lab Advocate
FDA Regulation of LDTs
As 2024 unfurls, ADLM proudly reflects on its determined advocacy of 2023 while setting its sights on future goals. As in previous years, a priority for the association is advocating against efforts to extend Food and Drug Administration (FDA) oversight to laboratory developed tests (LDTS). Legislation to establish this regulatory framework, the Verifying Accurate Leading-edge IVCT Development (VALID) was reintroduced in the 118th Congress in 2023, with supporters seeking to include the bill in Pandemic and All-Hazards Preparedness Act (PAHPA).
Members of ADLM’s Policy & External Affairs Core Committee visited Capitol Hill in June to educate legislators and staff about the negative consequences that VALID would produce, and advocated against its passage or inclusion in any legislation. As the legislation failed to gain any significant traction in Congress, the FDA has taken the regulatory approach to establish its authority over LDTs via the notice-and-comment rulemaking process. In October, the agency published a proposed rule, which if finalized, would create a costly, dual regulatory structure that would burden healthcare providers and prevent laboratories from developing and performing tests critical to ensuring quality patient care and medical practice.
This move was anticipated by ADLM. In December, the Board of Directors visited the Hill to voice the association’s concerns about this proposed regulation. In comments to the agency, and in outreach to key congressional offices, ADLM highlighted the negative impacts of this rule, emphasizing how it could stifle innovation, increase costs, and limit patient access to vital laboratory tests. The association underscored the importance of maintaining the current regulatory framework under CLIA, which has proven effective in ensuring the quality and safety of laboratory tests.
The association will continue its efforts in 2024 to prevent the FDA from extending its authority over LDTs.
CLIA Modernization
While FDA regulation of LDTs remains a major issue in the new year, a related area of focus for ADLM has been the ongoing debate on the modernization of the Clinical Laboratory Improvement Amendments (CLIA) regulations. Originally enacted in 1988, discussions regarding if or how CLIA should be modernized have periodically occurred over the years. The Clinical Laboratory Improvement Advisory Committee is currently working on this issue, and ADLM has been actively engaged in the policy debate.
The association has published three position statements outlining its views on the issue: Modernization of CLIA: Laboratory Developed Tests (LDTs), Modernization of CLIA: Certificate of Waiver Sites, and Modernization of CLIA: Moderate and High Complexity Testing. In addition, ADLM has submitted a number of comment letters to federal agencies regarding CLIA regulations over the years. The association emphasizes the importance of maintaining rigorous standards for accuracy and patient safety while maintaining CLIA’s ability to foster innovation and efficiency in the laboratory industry.
In a recent development, the Centers for Medicare and Medicaid Services (CMS) on December 28th published a final rule updating CLIA fees, personnel regulations, and provisions governing the imposition of sanctions and penalties for regulatory violations. ADLM is reviewing the final rule and will post a summary detailing key highlights in the coming days.
The Protecting Access to Medicare Act (PAMA)
ADLM has remained involved in efforts to ensure fair reimbursement for laboratory services. In a win for the lab community, a continuing resolution passed by Congress on November 15th - which provides funding for the government into 2024 - included a one-year delay in Protecting Access to Medicare Act (PAMA) reductions, thus averting payment cuts of up to 15% for a number of tests. This stop-gap measure can be credited to joint efforts of the laboratory community on this issue.
PAMA was enacted in 2014 with the intent to reflect market rates for laboratory services under Medicare. Unfortunately, the methodology employed by CMS captured data from fewer than 1% of labs and overrepresented large commercial organizations that benefit from economies of scale, thus skewing prices lower than Congress intended.
Legislation to address this issue, the Saving Access to Laboratory Services Act (SALSA), would establish a more accurate methodology of statistical sampling, as opposed to simply aggregating payment data self-reported from clinical labs, thus ensuring more representative payment data. This measure would provide the further benefit of greater price stability and reduce the administrative burden of price reporting on laboratories. ADLM endorsed the legislation shortly after its reintroduction in 2023 and joined with allies on Capitol Hill to advocate its passage. The association will continue to push Congress to adopt this measure 2024.
Laboratory Staffing Shortages
The association’s activities naturally extend to a number of other pressing issues facing labs. In early 2023, lab staffing shortages became a major area of focus, and ADLM convened a working group to examine new policy options to address the issue. This group’s effort and research resulted in a new white paper published over the summer that examines the root causes of the staffing problem and outlines potential actions that government and healthcare institutions could pursue to help resolve the ongoing crisis. ADLM also joined with other medical and public health laboratory workforce and healthcare organizations on a letter to key members of Congress on the Senate Health Educations, Labor Pensions and House Energy & Commerce Committees which outlines in detail the healthcare community’s recommendations on how the federal government can better address workforce shortages.
Pediatric Reference Intervals & Laboratory Test Harmonization
ADLM continues to forge ahead with its push to expand Congressional support for the harmonization of test results and the improvement of pediatric reference intervals (PRIs). The association has long led a broad coalition of healthcare stakeholders advocating for CDC funding to ensure more accurate diagnostic results and more informed treatments for children. On October 10th, ADLM, the Children’s Hospital Association, and the Endocrine Society, held a briefing on Capitol Hill to educate legislative staff about the need to improve the quality of pediatric reference intervals. Rep. John Joyce (PA-13), Co-Chair of the Children’s Health Caucus, provided opening remarks emphasizing the importance of this issue. ADLM has remained engaged with Rep. Joyce’s office and will continue to pursue this effort in 2024.
ADLM has also remained at the forefront of a coalition of healthcare organizations urging greater Congressional investment in CDC efforts to harmonize clinical lab test results. The association’s efforts thus far have yielded $2 million for the initiative annually since FY 2018, and the agency has made strides by improving the detection and management of various disorders and diseases. In coming months, ADLM will begin outreach with key congressional offices, aiming to increase this to $9.2 million for FY 2025.
In conclusion, ADLM's advocacy efforts in 2023 have been wide-ranging and impactful, from endorsing important legislation like SALSA to addressing workforce shortages and engaging in the CLIA modernization debate. The association's commitment to its members and the wider laboratory and healthcare community remains unwavering. As we move forward in 2024, ADLM anticipates a year filled with robust advocacy, progress, and growth, working towards a better-equipped, patient-responsive healthcare system.