During its policy committee meetings, PMC members debate and establish the Coalition's policy priorities and positions. These meetings frequently feature policy leaders, including representatives from the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and Congressional staffers, as guest speakers.
October 16, 2017
New Directions at CMS: A Discussion of the Agency's RFI on Improving Outcomes and Reducing Costs, featuring Steve Farmer, M.D., Ph.D., Senior Advisor, Medical Officer, Center for Medicare & Medicaid Innovation (CMMI)
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Materials to download:
December 14, 2017
Additional details will be provided closer to the event.
June 8, 2017
featuring staffers from the offices of Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO)
Staffers from the offices of U.S. Reps. Larry Bucshon, M.D., (R-IN) and Diana DeGette (D-CO) joined us to discuss the newly proposed draft legislative framework for the oversight of laboratory-developed tests (LDTs) outlined in the Diagnostic Accuracy and Innovation Act (DAIA). Jeff Lucas, Legislative Assistant for Rep. Bucshon, and Polly Webster, J.D., M.P.H., Health Policy Director for Rep. DeGette, shared their thoughts and took questions.
Following the discussion, PMC members reviewed the Coalition's responses to "The Preserving Employee Wellness Programs Act" (H.R. 1313) and a bill to provide for a study on the use of genetic testing to improve health care proposed by U.S. Rep. Eric Swalwell (D-CA). The final letters submitted are below:
April 27, 2017
featuring Marc Boutin, CEO, National Health Council
Marc Boutin, J.D., CEO, National Health Council, joined us to discuss how the 21st Century Cures Act, value assessment frameworks and Congress' consideration of the Affordable Care Act may impact patient access to personalized medicine.
The Coalition also considered Congress' recent activities in laboratory-developed test oversight and genetic privacy and discussed its responses.
February 15, 2017
featuring a question-and-answer period with FDA's Michael Pacanowski, M.P.H., Pharm.D., and an off-the-record conversation with Dylan Scott of Vox
Michael Pacanowski, M.P.H., Pharm.D., joined Daryl Pritchard, Ph.D., Vice President, Science Policy, PMC, to share his thoughts on the state of personalized medicine at FDA's Center for Drug Evaluation and Research and PMC's report titled Personalized Medicine at FDA: 2016 Progress Report. The meeting concluded with an off-the-record conversation with Dylan Scott of Vox, who offered his perspective on the new administration and answered questions from the audience.
The membership also discussed the Institute for Clinical and Economic Review (ICER)'s proposed updates to its value assessment framework. That conversation informed the Coalition's letter on the topic, which was submitted to ICER on April 3, 2017:
December 7, 2016
with PCORI's Joe V. Selby, M.D., M.P.H., and FDA's Elizabeth Mansfield, Ph.D.
Elizabeth Mansfield, Ph.D., Deputy Office Director, Personalized Medicine and Molecular Genetics, Office of In Vitro Diagnostics and Radiological Health, FDA, and Joe V. Selby, M.D., M.P.H., Executive Director, Patient-Centered Outcomes Research Institute (PCORI), discussed how their respective agencies plan to proceed in 2017. The Coalition also discussed its own plans for the new year.
June 21, 2016
Envisioning Value in Personalized Medicine, featuring Rick Chapman, Ph.D., M.S., Director of Health Economics, ICER with representatives from the Global Liver Institute, NPC and PhRMA
Rick Chapman, Ph.D., M.S., Director of Health Economics, Institute for Clinical and Economic Review (ICER), joined Donna R. Cryer, J.D., President & CEO, Global Liver Institute; Dan Leonard, President, National Pharmaceutical Council (NPC); and Randy Burkholder, Vice President, Policy and Research, Pharmaceutical Research and Manufacturers of America (PhRMA), for a discussion on personalized medicine technology value assessment.
April 21, 2016
with a panel of coding experts from AMA, McKesson and NextGxDx
A panel of coding experts discussed the Centers for Medicare and Medicaid Services (CMS)' options for implementing the Protecting Access to Medicare Act (PAMA) of 2014. The panel featured Jay Ahlman, Vice President, Coding & Reimbursement Products Portfolio, American Medical Association; Judsen Schneider, Ph.D., Vice President of Bioinformatics, NextGxDx; and Matthew Zubiller, Vice President, General Manager, Strategic Growth Portfolio, McKesson.
The membership also discussed the recently proposed Medicare Part B demo project. That conversation informed PMC's May 2016 letter on the topic:
February 24, 2016
with FDA's David Litwack and Taha Kass-Hout
David Litwack, Ph.D., Policy Advisor, FDA Office of In Vitro Diagnostics and Radiological Health, and Taha Kass-Hout, M.D., M.S., Chief Health Informatics Officer, FDA, and Director, Office of Health Informatics, FDA, delivered remarks on the role of databases in next-generation sequencing (NGS) policy and the intended impact of precisionFDA.