Fifth Annual LSI / ASU Law 2016 Molecular Diagnostics Workshop
On April 8, 2016, leading national physicians, regulators, attorneys, legal scholars, private and public healthcare enterprise representatives and patient care advocates took part in the Center’s Fifth Annual Regulatory and Reimbursement Obstacles and Drivers for Clinical Uptake of Molecular Diagnostics workshop in Scottsdale, AZ.
Center Faculty Director and Regents’ Professor of Law, Gary Marchant, welcomed the attendees and then gave FDA Director of the Office of In Vitro Diagnostics, Alberto Gutierrez the opportunity to provide an update on current agency initiatives and focus areas, including the 21st Century Cures Act, direct-to-consumer diagnostic tests, the President’s Precision Medicine Initiative and laboratory-developed tests. Gutierrez’ opening was followed by Louis Jacques, former Director, Coverage and Analysis Group Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services (CMS), who provided an annual CMS update.
A general key concept that resonated with the attendees with regard to reimbursement of clinical diagnostic tests was the importance of “quality of life over progression-free survival.”
A roundtable discussion on reimbursement trends was preceded by two presentations on topic. The first was by Donna Messner of The Center for Medical Technology Policy, a nonprofit organization focused on the development of a health care system where all stakeholders have the critical evidence necessary to make informed health care decisions. Among key issues, Messner discussed the controversial requirement of clinical utility and current coverage challenges, in particular with regard to next generation sequencing. The second presentation by Center Executive Council member and attorney Kirk Hartley, highlighted the concerns, problems and confusion with payer “experimental” reimbursement exclusions related to diagnostics and pharmaceuticals and noted the challenge of living up to the studies and proofs required for reimbursement. Hartley provided suggestions for improving the system, including short-term triage efforts and rejection of “one size fits all” experimental terms.
Specialized topics on: a) digital health, by Bruce Quinn, Senior Director of FaegreBD Consulting, a national advisory and advocacy group providing interdisciplinary services intersecting government and the private sector; b) molecular diagnostics and micro-sampling, by Amalia Issa, Founding Director, Program in Personalized Medicine & Targeted Therapeutics, University of the Sciences; c) the patient as payor by Laura Housman, Global Head, Therapeutics Business and Senior Vice President, Corporate Development of Molecular Health, a company that targets effective health care decision-making through its digital technology; and d) liability as a potential diagnostics applications driver, by Gary Marchant, were presented over the course of the afternoon, followed by another roundtable discussion on the noted topics. Ralph Hall, University of Minnesota Law School Professor of Practice, closed the workshop with an update on a proposed draft congressional initiative with regard to regulatory oversight of laboratory-developed diagnostic tests.
The Sixth Annual workshop is planned for Spring, 2017.
2016 Speakers (missing: Alberto Gutierrez)
Louis Jacques
Donna Messner
Kirk Hartley
Bruce Quinn
Amalia Issa
Laura Housman
Gary Marchant
Ralph Hall
Post workshop