Policy

Policy Meetings


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.

For questions about PMC's policy committee meetings, please contact David Davenport, Manager, Public Policy & Secretary to the Board. 

Upcoming Meetings


September, 26, 2018

featuring a discussion on Congressional efforts to reform the regulation of diagnostic tests

Materials presented:

The meeting will begin with a discussion among PMC members about Congress' recent activity to reform the regulatory oversight paradigm applicable to diagnostic tests. PMC Senior Vice President for Public Policy Cynthia A. Bens will lead the discussion, which will help inform PMC's next steps. 

During the business portion of the meeting, which will follow our conversation on diagnostics regulation, we will discuss, among other topics, the Centers for Medicare and Medicaid Services' recent actions regarding chimeric antigen receptor (CAR) T-cell therapies; evolving state approaches to coverage of FDA-approved next-generation sequencing tests; and PMC's proposed survey of health systems about the extent to which they have integrated personalized medicine in clinical settings.

Past Meetings


June 19, 2018

featuring Adam Berger, Ph.D. of the U.S. Food and Drug Administration

Materials presented:

Adam Berger, Ph.D., Senior Staff Fellow, Personalized Medicine, U.S. Food and Drug Administration (FDA), joined us to discuss the agency's efforts to develop a regulatory structure for digital health technologies that may help facilitate personalized care regimens.

During the business portion of the meeting, which followed our conversation with Dr. Berger, we examined PMC's progress on its Strategic Plan for 2018.


April 24, 2018

featuring Katherine B. Szarama, Ph.D., Lead Analyst, Decision Memo for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer, Centers for Medicare and Medicaid Services

Katherine B. Szarama, Ph.D., the lead analyst for the U.S. Centers for Medicare and Medicaid Services (CMS)' Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer, joined us to discuss the agency's recent decision to expand access to a subset of NGS tests approved by the U.S. Food and Drug Administration (FDA) for use in advanced cancer. 

During the business portion of the meeting, which followed, PMC members examined PMC's policy priorities, including appropriations to the U.S. National Institutes of Health and FDA; the Coalition's expanding list of working groups engaging patients, industry and providers; and a landscape analysis on the integration of personalized medicine into U.S. health systems. 

February 20, 2018
A Discussion of FDA's 2018 Priorities for Personalized Medicine, featuring a conversation with Laura M. Koontz, Ph.D., from FDA's Center for Devices and Radiological Health

Laura M. Koontz, Ph.D., Personalized Medicine Staff, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA), joined PMC members to discuss the agency's 2018 priorities in personalized medicine in the context of its efforts to advance the field in 2017, which are outlined in PMC's recently released Personalized Medicine at FDA: 2017 Progress Report.

During the business portion of the meeting, PMC members discussed, among other topics, the Coalition's plans to launch a patient advocacy organization working group and Fiscal Year 2019 appropriations to the FDA and NIH.

December 14, 2017
featuring a panel discussion on how value assessment frameworks may be designed to account for personalized medicine, followed by PMC's annual holiday party

A panel with Alan Balch, Ph.D. of the National Patient Advocate Foundation, Dan Leonard of the National Pharmaceutical Council, Kristen Migliaccio-Walle of Xcenda, and Dana Wollins of the American Society of Clinical Oncology (ASCO), moderated by PMC Senior Vice President, Science Policy Daryl Pritchard, Ph.D., discussed the role of personalized medicine in value assessment frameworks and PMC's latest white paper on the issue. 

During the business meeting that followed, PMC members discussed the Coalition's plans for 2018 and comment letters PMC submitted to CMS and the EMA. The white paper, strategic plan and comment letters discussed are below:

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)

Steve Farmer, M.D., Ph.D., Senior Advisor, Medical Officer, Center for Medicare & Medicaid Innovation (CMMI), joined us to discuss the future of value-based payment at the Centers for Medicare and Medicaid Services (CMS) in the context of the agency's recent request for information (RFI) on how to "drive quality, reduce costs and improve outcomes." Our conversation with Farmer, facilitated by PMC's Vice President for Public Policy, Cynthia Bens, informed the Coalition's effort to underline personalized medicine's benefits for both patients and the health system in its response to the RFI. The final letter submitted is below.

During the business portion, PMC members discussed PMC's comments on the European Medicines Agency (EMA)'s Concept Paper on Predictive Biomarker-Based Assay Development and comments on CMS' Outpatient Prospective Payment System Proposed Rule — Date of Service Provision, also known as the 14-Day Rule. The final letters submitted are below:

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.


October 11, 2016
The Map to a Million: An Update on the Precision Medicine Initiative

Stephanie Devaney, Ph.D., Project Manager, Precision Medicine Initiative (PMI), Office of the Chief of Staff, The White House, joined members of the Coalition to provide an update on the administration's progress toward sequencing one million genomes as part of the PMI. Dr. Devaney also gave an overview of its next steps. 

Members also discussed PMC's comment letters on next-generation sequencing (NGS), codevelopment of in vitro diagnostics and therapeutic products, and the Institute for Clinical and Economic Review (ICER)'s call for improvements to its value assessment framework.

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.

The conversation informed PMC's June 2016 letter on ICER's non-small cell lung cancer scoping document:

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.

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