ACLA Meeting Spotlights Value of Clinical Diagnostics in Face of Reimbursement, Regulatory Challenges

By Stephanie Murg, Managing Director, G2 Intelligence

Despite the looming challenges of a proposed overhaul of the Medicare payment system for clinical laboratory services and federal regulation of laboratory-developed tests, cautious optimism prevailed at the 21st annual meeting of the American Clinical Laboratory Association, held March 3 at the Grand Hyatt in Washington, D.C. With the theme of “Leading the Conversation on Diagnostic Innovation and Value,” the day-long conference brought congressional, regulatory, and administration leaders together with representatives from ACLA’s 38 member organizations as well as other stakeholders, and emphasized the role of laboratory medicine in the future of healthcare.

“Clinical laboratories are a critical part of the scientific innovation that has brought us to the forefront of personalized medicine and can be credited with helping to transform the practice of medicine and improve patient outcomes,” said ACLA President Alan Mertz, who described the previous 12 months as “busy but productive.”

Quest Diagnostics CEO and ACLA Chairman Steve Rusckowski concurred, characterizing the current “incredibly difficult time in the laboratory industry” as one in which labs are “at the end of our runway in terms of cost.” He emphasized the need for labs to play a much larger role in cutting costs and described the future as driven by innovation, strong partnerships, the leveraging of shared resources, and a renewed emphasis on patient-centric initiatives.

In brief comments on healthcare policies affecting diagnostics, House Ways and Means Chairman Kevin Brady emphasized the importance of “market-based” reform, particularly with regard to Section 216 of the Protecting Access to Medicare Act (PAMA). “Change is coming to Medicare,” said Brady of what would be the first major overhaul of the Clinical Laboratory Fee Schedule in three decades. “It’s a matter of getting the policy right and giving providers a chance to get there.”

Jeffrey E. Shuren, M.D., Director for Devices and Radiological Health for the Food and Drug Administration (FDA) addressed conference attendees on the agency’s views on the oversight of laboratory developed tests (LDTs). To the inevitable questions of timing, Shuren indicated only that “the intent” is to release the proposed guidance to regulate LDTs in 2016. When asked why the agency has chosen to proceed through guidance rather than a federal rulemaking process, he pointed to the greater transparency, accountability, and public input of the guidance process.

A keynote address by Bob Schieffer capped off the proceedings. Musing on the political landscape in this presidential election year, the veteran CBS reporter and former longtime host of Face the Nation began with a disclaimer of sorts. “No, I have never seen anything like what we’re seeing,” said Schieffer of the chaos created by Republican frontrunner Donald Trump. Having covered presidential elections since 1964, Schieffer placed the blame on a broken process, concluding, “This system has become so overwhelmed by money that serious people don’t want to [run for President] anymore.”