With the goal of improving patient care, promoting innovation, and ensuring high quality testing for all, the Association for Diagnostics & Laboratory Medicine’s (formerly AACC) advocacy efforts focus on four key areas: children’s health, laboratory regulations, patient access to quality testing, and reimbursement and the changing healthcare environment.
Laboratory testing plays a critical role in ensuring that infants, children, and adolescents receive high quality care. In particular, newborn screening—which is the practice of testing every newborn for endocrine, metabolic, and genetic disorders—prevents severe disability, developmental delays, or death in thousands of infants every year. The Association for Diagnostics & Laboratory Medicine (ADLM) actively supports efforts to enhance and expand newborn screening, and to improve interpretation of test results by developing better pediatric reference intervals.
Appropriate government oversight of clinical laboratories can contribute to the widespread provision of better, consistent care. However, unnecessarily onerous regulations hinder innovation and limit patient access to new scientific advancements. ADLM carefully considers the consequences of proposed regulatory actions prior to making any policy recommendations. This balanced approach is demonstrated by the association’s position on federal oversight of laboratory developed tests (LDTs). LDTs are created to fill unmet needs, such as when a commercial test is not available for a condition, or an existing test must be refined to address a unique patient situation. As such, LDTs are a key component of patient care and an important source of innovation in healthcare. ADLM backs public policies that improve the safety and effectiveness of these crucial tests, without hindering innovation or limiting patient access to care. As part of these efforts, the association has also been involved in discussions regarding potential updates to the Clinical Laboratory Improvement Amendments (CLIA) regulations, including whether these regulations should be updated and how.
Patient Access to Quality Testing
Access to quality, innovative testing is critical to the provision of good patient care. Clinicians use laboratory test results to diagnose disease and determine a treatment plan for their patients. Patients use these same results to monitor their health status. Unfortunately, patients’ lab results can disagree depending on where their tests are performed and what measurement procedures are used. ADLM supports harmonizing—or ensuring uniformity—among these test results so that patients receive the same diagnosis, regardless of where they get tested. Harmonization can improve patient care and outcomes by leading to better clinical guidelines and fewer medical errors, and by increasing patient involvement in care decisions.
Since the outset of the pandemic, the association has worked to help ensure patients have access to timely, accurate COVID-19 testing. ADLM continues to be a vigorous advocate for policies that support laboratories as they work to meet the demand for testing.
Reimbursement and the Changing Healthcare Environment
Healthcare delivery and provider payment models are changing. For years, Medicare has favored a fee-for-service (FFS) model, in which individual providers are reimbursed for the individual services they perform. Laboratory FFS payment rates are set annually under the Clinical Laboratory Fee Schedule (CLFS). Recent CLFS rates have been subject to drastic cuts as a result of the flawed implementation of the Protecting Access to Medicare Act. The association is working closely with its lab partners to improve the fee schedule.
Increasingly, Medicare is transitioning away from FFS towards a coordinated care system that requires providers to achieve certain quality measures to receive payments. Coordinated care necessitates participation on the care team by all key experts, including those in laboratory medicine. ADLM actively promotes the value of lab medicine experts on the care team. The association also serves as a member of the National Quality Forum, providing the voice of laboratory medicine in the promulgation of new quality measures. The delivery of healthcare and Medicare reimbursement are key priorities for ADLM.
Read ADLM’s position statements and comment letters to learn more about these and other government issues of importance to laboratory scientists.