ADLM submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed revisions to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center payment system. Among the proposals, CMS would establish a new payment policy for certain software-based medical services that use algorithms to analyze clinical data. CMS argued that these services may not qualify as clinical laboratory tests and therefore should no longer be reimbursed through the Clinical Laboratory Fee Schedule (CLFS). ADLM urged the agency to withdraw this proposal and instead engage stakeholders in a broader discussion about how these emerging technologies should be regulated.
A key concern ADLM raised is that laboratory medicine remains essential even after a test result has been produced. While CMS suggests that certain secondary analyses can be separated from the testing process itself, ADLM argues that laboratorians play a critical role in understanding the limitations, quality, and clinical significance of laboratory data. Algorithms can support clinical decision-making, but they cannot replace the scientific judgement needed to recognize potential issues that could affect patient care.
ADLM also emphasized that laboratory results are not always comparable across testing methods and platforms. Many tests are not fully harmonized, which as a result, can cause algorithmic tools that rely on data from multiple sources to generate inaccurate conclusions, if the differences are not properly accounted for. ADLM cautioned that overlooking these limitations could increase the risk of misdiagnosis and unnecessary healthcare costs.
As artificial intelligence and advanced data analytics become increasingly integrated into healthcare, ADLM supports thoughtful policies that foster innovation while maintaining strong safeguards for patients. ADLM will continue to advocate for a science-based, objective grantmaking process that supports rigorous research and ensures federal investments advance laboratory medicine, public health, and patient care.