Federal Policy Update: FDA’s Lab Developed Tests Proposed Rule
The federal landscape concerning lab developed tests (LDTs) is shifting, with significant implications for laboratories and healthcare providers. Julie Barnes, Principal of Maverick Health Policy, reports that the government has updated classifications, now treating in vitro diagnostics as medical devices regardless of manufacturing origin, which impacts laboratory developed tests. This move initiates a four-year transitional period to new regulatory oversight, while acknowledging the need to grandfather certain established tests. Amidst concerns, there’s an active Request for Information (RFI) about the impacts on academic medical centers, with the potential for specific carve-outs to support their work. Notably, industry bodies like ACLA and AdvaMed are challenging the rule, questioning the FDA’s authority and resources, and advocating for the VALID Act to be passed by Congress instead. This regulatory turbulence comes in the wake of rapid LDT expansion and high-profile patient safety concerns, exemplified by the Theranos scandal.
Biomarker Legislation: A Post-diagnosis Coverage Mandate
Alex Sommer, VP of State Government Affairs, articulates the transformative journey from the Human Genome Project to the current landscape of genetic testing, emphasizing the pivotal role of precision health in enhancing patient care. Precision health is anchored in three pillars: personalized treatment plans, targeted therapies for improved outcomes, and minimizing side effects to elevate patient experiences. He stresses the importance of accurate biomarker testing that relies on the science to realize this vision. States are actively pursuing access to such testing, guided by the MODEL act, which requires biomarker testing to be in scope when there is clear clinical and scientific evidence of a test’s optimization of patient care.
Current Biomarker Status: What We Are Seeing
Lindsey Abraham, VP of Government Programs, delves into the legislative nuances defining biomarkers. The MODEL act, under discussion for over a year, sets out a post-diagnosis coverage mandate, embracing a broad definition of biomarker testing, encompassing tissue, blood, or biospecimen analysis. The aim is to ensure that the right tests lead to the right treatments. However, this breadth brings challenges: the potential for overuse, inconsistency in implementation, and cost sustainability concerns. She emphasizes that alignment with nationally recognized guidelines and evidence-backed clinical utility are paramount to ensure that mandates don’t inadvertently hinder innovation or inflate healthcare costs. To date, 14 states have enacted biomarker bills, with more on the horizon, driven by both patient needs and political interest.
Coverage Considerations: The Right Test, For the Right Care
Sarah Bretz, Product Manager, underscores how Avalon’s solutions are poised to assist payers in navigating these changing tides. Avalon’s offerings aim to balance cost and care efficacy, leveraging evidence-based policies to ensure appropriate test utilization. With the ever-growing list of genetic tests, Avalon’s approach is to streamline the test management process, providing a framework that ensures the right patient gets the right test at the right time, effectively reducing unnecessary expenses. Avalon’s network of lab providers and precision management capabilities are key tools in this endeavor. Avalon promotes “science as the truth north” while adhering to the evolving legislative landscape. As the push for precision medicine and value-based care continues to accelerate, Avalon’s strategies and products offer a way for health payers and professionals to stay ahead of the curve, ensuring that policy changes translate into tangible benefits for all.