Empowering Clinicians with the Latest FDA-Approved Screening Technologies

In the U.S., a significant barrier to ensuring high quality health care is our very complex regulatory environment. As the pace of innovation continues increasing rapidly, it is critical that our policy infrastructure evolves to meet the moment.

Diagnostic innovators and medical technology leaders continue to develop health screening tools that are faster, safer, more accurate, and accessible by more people. Yet quality measures tied to both reimbursement policy and assessment of Medicare Advantage plans from the Centers for Medicare & Medicaid Services (CMS) struggle to keep pace with the rate of innovation in FDA-approved diagnostic technologies that could save countless lives.

These measures can take more than a decade to update, meaning clinicians are not incentivized to adopt the latest diagnostics—not due to concerns about efficacy or safety, but because innovation has outpaced the policy infrastructure meant to oversee it.

Recognizing the need for more options, Rubrum recently launched the Alliance for Screening Measurement Modernization (ASMM)—a cross-sector coalition of healthcare stakeholders that will explore how to broaden the pathways by which new screening technologies are incorporated into health quality measures.

Currently, guidelines published by the U.S. Preventive Services Task Force (USPSTF) impact how these measures are updated. While the Task Force is the optimal organization to lead this work, it lacks the funding and resources to do so. Considering additional pathways to update the measures will help the system keep pace with clinical innovation, ease administrative burden for providers, and support more predictable market adoption for industry. Ultimately, this will enable a more dynamic, responsive infrastructure that evolves in tandem with the science—and ensures patients have access to the best technologies to detect serious illness.

Over the next six months, ASMM will:

• Develop a replicable, transparent framework to support measure developers with timely and appropriate pathways to update currently endorsed screening quality measures
• Enable the evidence-based inclusion of innovative technologies that improve diagnostic speed, accuracy, and accessibility
• Submit a consensus white paper and policy briefs to Congressional and federal agencies for consideration

ASMM is structured to ensure that innovators have a seat at the table and is led by two distinct but collaborative bodies:

• The ASMM Quality Council, composed of independent guideline-setting groups and nonprofit organizations, which will create the technical framework.
• The Industry Council, which includes leaders in diagnostic and imaging innovation, and will serve as the central forum to ensure industry stakeholders have a voice in the process.

Together, these councils represent a comprehensive spectrum of expertise—from evidence-based clinical best practices to regulatory strategy—that will help ensure the framework is grounded in real-world application.

In today’s world, patients expect modern, convenient, and minimally invasive screening and diagnostics. Clinicians want tools that align with evolving evidence and enhance care delivery. Diagnostic and MedTech companies want a faster pace and a more predictable process. And CMS is focused on delivering improved outcomes, especially in care for chronic diseases like cancer, diabetes, and cardiovascular disease. By strengthening the infrastructure that determines how quickly approved screening technologies reach the front lines of care, ASMM and its members are creating an unprecedented opportunity to help meet these needs.