Examining Policy That Will Support Innovation, Personalized Medicine


Policymakers are facing pressure to control federal spending and lower the national debt, with healthcare costs as a focal point of debate to address this pressure. The path that policymakers take will have a significant impact on biomedical progress, the role of U.S. companies as global leaders in life science innovation, and the quality of patient care.

One example of how policy can impact healthcare innovation is playing out right now. The Centers for Medicare and Medicaid Services (CMS) 2013 Gapfill Payment Amounts and Clinical Laboratory Fees Schedule (CLFS) charged regional Medicare Administrative Contractors (MACs) to set new prices for molecular diagnostic test reimbursement through a process called “gapfilling.” This process has resulted in much lower payment amounts for molecular diagnostics which has had unintended consequences.  Some innovators have reported that drafting cooperation agreements to bring new targeted therapies to market has been stifled. Some clinical labs have reported that they might not be able to offer some tests since new payment rates do not cover the costs of running them, which may negatively impact patient access to diagnostic tests and appropriate treatments.

The Personalized Medicine Coalition (PMC) submitted comments to CMS on the Gapfill Payment Amounts and CLFS, iterating the concerns of PMC members that insufficient payment amounts threaten the sustainability of the laboratory industry and continued investment in the developing field of personalized medicine. As a consequence, this policy has the potential to stifle innovation and progress in healthcare and possibly eliminate the potential for lowering overall costs through the elimination of unnecessary and or ineffective treatments.

With dramatic advances in science, it has become more important than ever to ensure that policymakers understand the value of biomedical innovation and support pathways that encourage continued advancement and yet we see deficit reduction pressures regularly resurfacing in new healthcare policies.

To that end, PMC is hosting a Congressional Briefing on Monday, July 22. We will examine the role personalized medicine plays in healthcare and how our public policy can drive progress and innovation. At the briefing, PMC will unveil policy principles to ensure that proposed cost-containment efforts do not undermine personalized medicine, but instead, protect innovation, the physician-patient relationship, and patient values and choice. We also will hear the diverse perspectives on innovation from lung cancer survivor and patient advocate, Stephanie Haney; drug developer, Dr. Stephen Eck; diagnostic developer, Patrick Balthrop; and physician, Dr. Amy Abernethy.

At PMC, we look forward to our continued collaboration with the stakeholder community to identify opportunities for public policy to drive progress and innovation.

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