ACLA News

ACLA’s 20th Annual Conference Gathers Legal, Congressional & Regulatory Leaders on FDA’s Role with LDTs, Reimbursement and the Future of Personalized Medicine

WASHINGTON, DC –  Scientists, physicians, researchers and lab clinicians will gather today in the nation’s capital to hear lawmakers, regulatory officials and legal experts address the most pressing policy issues of the day for clinical labs at the 20th annual conference of the American Clinical Laboratory Association (ACLA).

“The beginning of the 21st century has seen an explosion of diagnostic innovation that is rapidly changing the practice of medicine.  We are providing diagnostic insights that can improve patient outcomes and empower people to make informed health care decisions,” said Steve Rusckowski, Chairman of the ACLA Board of Directors and CEO of Quest Diagnostics. “Clinical labs are at the forefront of this new era and are taking a leadership role in ensuring smart public policy keeps pace with innovation.”

ACLA’s expert legal counsel, former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University, will provide conference attendees with a legal perspective to the Food and Drug Administration’s (FDA) move to regulate laboratory developed tests (LDTs). Messrs. Tribe and Clement issued a white paper earlier this year rejecting the FDA proposal to extend its regulatory authority LDTs by reclassifying them as medical devices.

The program also includes Senator Richard Burr (R-NC) giving an overview of congressional action on health care policy, Marc Hartstein, Director of the Hospital and Ambulatory Policy Group for the Centers of Medicare and Medicaid Services (CMS) updating the audience on Medicare reimbursement for clinical labs and Elizabeth Mansfield, Director of Personalized Medicine at the FDA, informing attendees of that agency’s relevant regulatory initiatives. In addition, former Chief Political Correspondent for CNN, Candy Crowley, is scheduled to deliver the keynote address on the nation’s political landscape and the upcoming 2016 presidential election.

“ACLA has a remarkable record of success in advocating on behalf of its members on legislative and regulatory issues impacting the coverage, payment and regulation of laboratory testing,” said Alan Mertz, President of ACLA.  “Our annual conference and this year’s all-star line-up of speakers provides a great opportunity for clinical labs to interact with the nation’s health care decision-makers.”

To access the full agenda for ACLA’s annual conference May 4 – 5 at the Grand Hyatt Hotel, click here.

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