This session explores the FDA’s recent rulemaking efforts surrounding Laboratory Developed Tests (LDTs) and their impact on patient testing. It highlights the regulatory shifts aimed at ensuring the safety, effectiveness, and reliability of LDTs, while addressing challenges faced by laboratories in complying with new standards. Key lessons learned from this regulatory evolution are discussed, including implications for patient care, diagnostic innovation, and the balance between clinical flexibility and regulatory oversight.

This presentation will discuss how the new regulations might affect the development and adoption of personalized diagnostic tests. Key points include balancing innovation with regulatory compliance; potential effects on patient access to novel tests; and impact on rare disease testing and oncology diagnostics.

Biomarker testing is guideline-recommended, but many systemic barriers lead to underutilization of testing and targeted therapies that benefit patients. The way that biomarker testing is evaluated differs by stakeholders in ways that overlap and diverge. In this session, we explore the outcomes of biomarker testing by stakeholders and identify opportunities for evidence generation and framework expansion to enhance access to guideline-recommended care.

In recent years, state legislators have introduced dozens of measures requiring health insurers to cover a diverse array of biomarker tests. This surge in legislative activity reflects policymakers' commitment to enhancing access to biomarker testing. However, it also signifies a significant shift in market dynamics, presenting implementation challenges for affected stakeholders. Join us as we explore the evolving landscape of coverage and patient access within this dynamic field of medicine.

In general, healthcare in the United States tends to be reactive. Precision Medicine, including germline and somatic testing as well as pharmacogenomics, aims to shift healthcare from reactive to proactive. Among the key challenges to implementing precision medicine is payor coverage for testing and services. Recent and pending legislation aims to address these challenges. This presentation will address the key challenges and legislative efforts to enhance implementation of precision medicine, with a particular focus on pharmacogenomics and proactive care.

In 2020, Medicare LCDs started rolling across the country that aligned pharmacogenomics (PGx) testing coverage with evidence based CPIC guidelines or FDA pharmacogenetic association guidance. The American Cancer Society Cancer Action network, noting that many evidence-based genetic tests were not covered by insurance, launched a biomarker testing campaign to align commercial and Medicaid insurance coverage for somatic and germline genetic testing, including PGx, with the evolving evidence. Meanwhile, federal efforts such as the Right Drug Dose Now Act are aiming to address other barriers to realizing the promise of precision medicine in improving patient care. Learn about these legislative efforts and how they can impact patient care delivery.