Policy

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 Lindsay Stephens, Program Manager & Secretary to the Board.

Upcoming Meetings

June 9, 2022; 12:00 - 2:00 p.m. ET
The Future of Medicare Coverage in Personalized Medicine: Exploring The Potential Impact of a TCET Pathway

Materials:

Steven Farmer, M.D., Ph.D., who serves as the Centers for Medicare and Medicaid Services (CMS)' Chief Strategy Officer for Coverage and Senior Medical Officer for the Center for Clinical Standards and Quality, will join us at the beginning of the meeting to discuss the agency's consideration of a transitional coverage for emerging technologies (TCET) pathway. As a follow-up initiative to the repeal of the Medicare Coverage of Innovative Technology (MCIT) pathway, the TCET effort is considering how to achieve timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards. The TCET pathway could alter the coverage outlook for products and services underpinning personalized medicine by facilitating transitional coverage of future diagnostics and other enabling technologies.

During the following business meeting, PMC members will discuss the Coalition’s latest efforts to advance personalized medicine, including updates on the Coalition's evolving research program, activities around user fee reauthorization,  and additional advocacy on regulatory and reimbursement issues.

Additional September and December meeting dates forthcoming

Past Meetings

April 19, 2022; 12:00 - 2:00 p.m. ET
Personalized Medicine in 2022: A Virtual Discussion of PMC's Plans and Progress So Far

Materials:

As PMC strives to help shape a favorable landscape for advancing personalized medicine in 2022, members discussed the Coalition's recent work and planned activities, including updates on the publication of a new comparative analysis flagging incongruities in information about drug-gene associations listed by the U.S. Food and Drug Administration and the Clinical Pharmacogenetics Implementation Consortium; the publication of a new economic modeling study suggesting that broad-based genomic profiling tests may be the most cost-effective tools for diagnosing acutely ill infants who are less than a year old with suspected rare genetic diseases; PMC's activities around Cures 2.0 and user fee reauthorizations; and PMC's additional advocacy on regulatory and reimbursement issues.

Bruce Quinn, M.D., Ph.D., a consultant and former Medical Director for California Medicare, also joined us to share his views on "Medicare Policy and Innovation in Personalized Medicine" at the beginning of the meeting. Dr. Quinn published an April 8 opinion article on the topic for Inside Precision Medicine.

March 2, 2022; 12:00 - 2:00 p.m. ET
Personalized Medicine at FDA

Materials:

With attention to the insights contained in PMC's recently released report titled Personalized Medicine at FDA: The Scope & Significance of Progress in 2021, the U.S. Food and Drug Administration (FDA)'s Michael Pacanowski, M.P.H., Pharm.D., who serves as Clinical Pharmacology Director of Translation and Precision Medicine in FDA's Center for Drug Evaluation and Research, and Wendy Rubinstein, M.D., Ph.D., who serves as the Director of Personalized Medicine in the Office of In Vitro Diagnostics and Radiological Health, part of the Center for Devices and Radiological Health, joined us during the meeting to share their views on the state of personalized medicine at FDA.

Following the remarks from Drs. Pacanowski and Rubinstein, PMC members discussed the Coalition’s progress and plans for the year with reference to its evolving research program focused on understanding and delivering the clinical and economic benefits of personalized medicine as well as its legislative and regulatory priorities for 2022.

December 2, 2021; 12:00 - 2:00 p.m. ET
Dynamic Scoring and Personalized Medicine

Materials:

American Action Forum President and former CBO Director Douglas Holtz-Eakin, Ph.D., joined us to discuss how the "dynamic scoring" budgetary impact analysis methodology may impact the prospects for future public policies that could influence the pace of progress in personalized medicine. In response to PMC members who have expressed an interest in learning more about how Congress uses dynamic scoring to inform legislative decision-making, Dr. Holtz-Eakin discussed the process and history behind dynamic scoring and how it could be a positive or negative force for advancing personalized medicine.

During the business portion of the meeting, PMC members discussed the Coalition's latest efforts to advance personalized medicine, including updates on: PMC's advocacy around Cures 2.0 and the Precision Medicine Answers for Kids Today Act; PMC's 2022 research program, including a new initiative titled Payer Perspectives and Policies on Personalized Medicine: A Landscape Analysis; and PMC's 2022 Policy Agenda.

September 14, 2021; 12:00 - 2:00 p.m. ET
The Future of Medicare and Medicaid Innovation in Personalized Medicine

Materials:

Lara Strawbridge, M.P.H., who serves as the Director of the Centers for Medicare and Medicaid Services Innovation Center (CMMI)'s Division of Ambulatory Payment Models in the Patient Care Models Group, joined us during the second half of the meeting to discuss the Biden Administration's vision for the CMMI as it relates to personalized medicine. In her role at CMMI, Ms. Strawbridge leads CMS’ efforts on physician specialty models such as the Oncology Care Model. She also leads the Center's work on Part B drug issues.

During the preceding business meeting, which took place from 12:00 to 1:30 p.m. ET, PMC members discussed the Coalition’s latest efforts to advance personalized medicine, including updates to PMC’s principles on regulatory oversight of laboratory-developed tests (LDTs), the Coalition’s feedback on the 21st Century Cures 2.0 Discussion Draft, PMC’s process for engaging members in developing its 2022 policy priorities this fall, and updates on PMC’s research program.

June 24, 2021
Reviewing Progress Toward the Clinical Adoption of Personalized Medicine

Materials:

To kick off the meeting, Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, PMC, reviewed the results of a new landmark study in the Journal of Personalized Medicine applying a quantitative multi-factorial framework to assess the clinical adoption of personalized medicine among a representative sample of 153 health care providers in the United States.

During the business portion of the meeting, PMC members discussed the Coalition's latest efforts to advance personalized medicine, including updates on PMC’s research program, the Advancing Access to Precision Medicine Act, and reimbursement for chimeric antigen receptor (CAR) T-cell therapies under CMS’ Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule for FY 2022.

April 21, 2021
A CDC Perspective on Personalized Medicine & Precision Public Health

Materials:

Muin J. Khoury, M.D., Ph.D., Director, Office of Genomics and precision Public Health, U.S. Centers for Disease Control and Prevention (CDC), joined us to share his perspective on the future of personalized medicine and precision public health.

Following Dr. Khoury's discussion of the evolution of "precision public health" in common, rare, chronic, and infectious diseases and how his division at CDC is carrying this work forward, PMC members discussed the Coalition's latest efforts to advance personalized medicine, including multiple legislative efforts in the new Congress to advance personalized medicine, CMS' Medicare Coverage of Innovative Technology pathway for breakthrough devices, and MedPAC's recent report on Telehealth in Medicare After the Coronavirus Public Health Emergency. 

February 23, 2021
Expanding the Frontiers of Personalized Medicine in 2021

Materials:

Representing the U.S. Food and Drug Administration's Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER), Michael Pacanowski, Pharm.D., M.P.H., and Robert Schuck, Ph.D., Pharm.D. joined us to share their views on the state of personalized medicine at CDER. Dr. Pacanowski serves as the Office's Acting Director for Translational and Precision Medicine while Dr. Schuck serves as Clinical Pharmacologist for Genomics and Targeted Therapy.

Following the remarks from Drs. Pacanowski and Schuck, PMC members discussed the Coalition’s progress and plans for the year against the backdrop of a shifting public policy environment. Topics for discussion included PMC's recently published analysis of personalized medicine tests and treatments approved by FDA in 2020; its evolving research program focused on understanding and delivering the clinical and economic benefits of personalized medicine; and its legislative and regulatory priorities for 2021.

December 15, 2020
Assessing the Landscape for Advancing Personalized Medicine in 2021

Materials:

Reps. Eric Swalwell (D-CA) and Scott Peters (D-CA) joined the meeting of PMC's Public and Science Policy Committees on December 15 from 12:15 to 1:00 p.m. ET to discuss H.R. 4144: Ending the Diagnostic Odyssey Act and H.R. 4393: Advancing Access to Precision Medicine Act. Rep. Swalwell's Chief of Staff, Michael Reed, and Health Policy Advisor, Adeola Adesina, attended the meeting alongside Rep. Peters' Chief of Staff, Daniel Zawitoski, to discuss the two bills proposing coverage of sequencing services for certain individuals, including the prospects for reintroduction of the bills in the next Congress and how PMC members can be helpful in ensuring that legislation in this area can best meet the needs of patients.

During the business meeting, PMC members discussed progress and direction in advocacy and evidence development, with reference to PMC's research agenda and forthcoming Policy Agenda for 2021, President Trump's "most favored nations" executive order on reference pricing, and the sixth edition of PMC's signature document, The Personalized Medicine Report: Opportunity, Challenges, and the Future

September 24, 2020
Advancing Genomic Testing and Patient Priorities for Personalized Medicine

Materials:

During the business meeting, PMC discussed the insights from a new PMC report on genomic testing utilization and coverage in the United States, considered the priorities defined in its new patient-centered research agenda for personalized medicine, and began shaping the Coalition's agenda for 2021.

To kick off the meeting, PMC Manager of Public Policy David Davenport and Senior Vice President for Science Policy Daryl Pritchard, Ph.D., summarized the insights from Moving Beyond Population Averages: A Patient-Centered Research Agenda Advancing Personalized Medicine and Understanding Genomic Testing Utilization and Coverage in the US. Following their presentations, the policy committee considered next steps in advocacy and evidence development with reference to PMC's research program to understand and deliver the clinical and economic benefits of personalized medicine, President Donald Trump's "most favored nations" executive order on reference pricing, and PMC's 2021 planning process and related discussion questions.

June 29, 2020
Defining Priorities for the Field Against the Backdrop of COVID-19

Materials:

During the business meeting, PMC members discussed their latest advocacy and evidence development activities to advance personalized medicine against the backdrop of the COVID-19 pandemic. 

In addition to sharing their thoughts on how the COVID-19 pandemic will impact personalized medicine, updates were shared on responding to U.S. Reps Diana DeGette (D-CO) and Fred Upton (R-MI)'s 21st Century Cures 2.0 Concept Paper, advocating for improved reimbursement pathways for chimeric antigen receptor (CAR)T-cell therapies, and advancing PMC's research program and sponsorship opportunities supporting the study of the clinical and economic utility of personalized medicine in multiple disease states, including PMC's initiative to understand genomic testing utilization and coverage in the U.S.

May 7, 2020
Personalized Medicine in the Era of COVID-19

Materials:

During the business meeting, PMC members discussed their latest advocacy and evidence development activities to advance personalized medicine against the backdrop of the COVID-19 pandemic. Given the exigencies of the moment, the meeting was held virtually and shortened to one hour.

In addition to sharing thoughts on how the COVID-19 pandemic would impact personalized medicine, we discussed our efforts to recruit additional members for the Congressional Personalized Medicine Caucus, advocate for improved reimbursement pathways for chimeric antigen receptor (CAR) T-cell therapy and advance PMC's Research Program Studying the Clinical and Economic Utility of Personalized Medicine in Multiple Disease States.  

Prior to the meeting, we encouraged review of the following summary from February's month's meeting - Action Items: A Meeting of PMC's Public and Science Policy Committees (February 27, 2020).

February 27, 2020
featuring staff from the offices of the Congressional co-chairs of the new bicameral, bipartisan Personalized Medicine Caucus

Materials:

Staff from the offices of the Congressional co-chairs of the new bicameral, bipartisan Personalized Medicine Caucus joined the meeting of PMC's Public and Science Policy Committees on February 27 to discuss their respective members' interests in personalized medicine and the caucus' introductory briefing on the benefits of earlier detection, targeted treatment, and improved prevention strategies, which was scheduled for February 26. Our featured speakers during the committee meeting included Adeola Adesina, Legislative Assistant, Office of Rep. Eric Swalwell (CA-15) and Catherine Lenz, Legislative Assistant, Office of Rep. Tom Emmer (MN-06).

During a business meeting following the conversation with Adesina and Lenz, PMC members discussed the latest policy developments impacting personalized medicine including, recruiting members of Congress to join the Congressional Personalized Medicine Caucus, PMC’s ongoing and proposed evidence development projects and sponsorship opportunities, PMC’s activities in pharmacogenomics, the Verifying Accurate Leading-edge IVCT Development (VALID) Act and H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act.

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