The Researcher, Physician, Regulator, and Patient in an Age of Personalized Medicine

Transcription

1 Thursday, March 22, 2012 Breakfast 7:30 to 8:15 am Welcome and Introductions 8:15 to 8:30 am Session One 8:30 to 10:30 am NATIONAL COALITION FOR CANCER SURVIVORSHIP CANCER POLICY ROUNDTABLE March 22-23, 2012 AGENDA The Researcher, Physician, Regulator, and Patient in an Age of Personalized Medicine The past year has seen the approval of targeted cancer therapies and progress toward the development of more. The meeting s opening panel will evaluate the movement toward targeted, or personalized, cancer therapies and the impact of research and clinical development of such therapies on the continuum of cancer research and care. The panel will consider in greater depth the questions and concerns identified by participants in the targeted therapies panel at the October 2011 Cancer Policy Roundtable. The panelists will discuss the challenges and opportunities associated with research and development of targeted therapies, the response of the Food and Drug Administration to these developments, and the potential benefits for cancer survivors. Panelists will also consider the necessity for open and complete communication between health providers and patients regarding the availability of targeted therapies and their risks and benefits, communication that is necessary to inform treatment decision-making. Jamey Skillings, M.D., M.SC. Vice President Medical Affairs Pfizer Gregory H. Reaman, M.D. Associate Director Office of Oncology Drug Products Food and Drug Administration Clifford A. Hudis, M.D. Chief, Breast Cancer Medicine Service Memorial Sloan-Kettering Cancer Center Fran Visco President National Breast Cancer Coalition

2 Session Two 10:30 to 11:00 am Changes in Oncology Practice Models, Payment, and Location: The Impact of Health Reform and Delivery Reform Health reform has been enacted and implemented in Massachusetts, and Affordable Care Act (ACA) implementation is underway to meet the 2014 date for full functioning of the health insurance exchanges of the ACA. Many suggest that health delivery reforms will continue, even if the challenge to the ACA is successful. Cancer care providers and patients are already experiencing and observing changes in the delivery of cancer care, including shifts in the site of care, new requirements for reimbursement, evolving standards for quality reporting, and patient cost-sharing requirements that can be confusing and economically burdensome. This panel will identify and discuss changes in cancer care delivery, reimbursement, and quality improvement. Patrick H. Conway, M.D., M.Sc. Chief Medical Officer Centers for Medicare & Medicaid Services Break 11:00 to 11:15 am Session Two (Continued) 11:15 am to 12:30 pm Therese M. Mulvey, M.D. Physician-in-Chief/Medical Oncologist Southcoast Health System Massachusetts Ira Klein, M.D., M.B.A., F.A.C.P. Aetna Oncology Solutions Aetna Joseph O. Jacobson, M.D. Chief Quality Officer Dana-Farber Cancer Institute John V. Cox, D.O., M.B.A. Texas Oncology Dallas, Texas 2

3 Session Three 12:30 to 1:00 Implementation of the Affordable Care Act: Highlights of Recent HHS Activity Jay Angoff Senior Advisor and Acting Region VII Director Department of Health and Human Services Lunch 1:00 to 1:30 Session Four 1:30 to 3:30 pm Essential Health Benefits: The Impact on Patients and Health Providers The panel will consider the Department of Health and Human Services (HHS) bulletin on essential health benefits that provides states considerable flexibility in the administration of exchanges by permitting them to choose among a range of benchmark health plans. The panel will consider this approach from the perspective of cancer survivors, health care professionals, and researchers, and will evaluate its impact on cancer care quality. The panel will also compare the approach recommended by HHS to the standards recommended by the Institute of Medicine in its report on the determination of essential health benefits. Katherine Hayes, J.D. Associate Research Professor Department of Health Policy The George Washington University School of Public Health and Health Services George Washington University J. Leonard Lichtenfeld, M.D., MACP Deputy Chief Medical Officer American Cancer Society Gregory Gierer, M.P.P. Vice President Policy and Regulatory Affairs America s Health Insurance Plans (AHIP) Joshua M. Sharfstein, M.D. Secretary Department of Health and Mental Hygiene State of Maryland 3

4 Session Five 3:30 to 5:00 pm Drug Shortages: The Impact on Cancer Patients and Providers and Strategies for Solving the Problem Shortages of sterile injectables and other products for treatment of cancer have had a substantial impact on cancer care. Patients have experienced long-term and potentially harmful disruptions in their care, and providers have confronted significant challenges in attempting to obtain drugs for appropriate treatment of their patients. Policymakers are actively pursuing solutions to the persistent problem of drug shortages, and they have recently received recommendations from the Government Accountability Office (GAO) for addressing the drug shortage crisis. The session will review GAO recommendations, legislative proposals, and other policy options to eliminate drug shortages. CAPT Valerie Jensen R.Ph. Associate Director CDER Drug Shortage Program, Food and Drug Administration CDR Christine Bina, R.Ph, MPH Senior Program Management Officer CDER Drug Shortage Program, Food and Drug Administration Michael P. Link, M.D. President, American Society of Clinical Oncology Professor, Pediatrics Hematology & Oncology Stanford University School of Medicine Daniel Todd, J.D. Health Policy Advisor Senate Finance Committee Scott Gottlieb, M.D. Resident Scholar American Enterprise Institute 4

5 Friday, March 23, 2012 Breakfast 8:00 to 9:00 am Session Six 9:00 to 10:00 am Tell It Like It Is: Improving Access to Better Quality Cancer Care and Better Quality of Life Cancer patients in 2012 may benefit from cutting-edge targeted therapies and coordinated care that integrates palliative care with oncology care. Or they may experience seriously fragmented care that does not afford them either the best in oncology care or palliative care. Dr. Smith will discuss the challenges associated with delivery of high-quality cancer care, including the issues related to the cost of care for the individual and the health care system, care planning and coordination, and access to palliative care. Thomas J. Smith, M.D., FACP Director of Palliative Medicine, Johns Hopkins Medical Institutions Professor of Oncology, Sidney Kimmel Comprehensive Cancer Center Harry J. Duffey Family Professor of Palliative Medicine Session Seven 10:00 to 11:00 am The Affordable Care Act: Supreme Court Review This session falls just days before Supreme Court oral arguments on the Affordable Care Act (ACA) schedule for March 26-28, This session will provide an overview of the ACA issues the Court has agreed to hear, the arguments outlined in the parties briefs (including the amicus briefs), and the commentary about the direction the Court may take in its analysis and decision. Ian Millhiser, J.D. Policy Analyst Center for American Progress Wrap-up Questions and Discussion of Next Meeting s Agenda 11:00 to 11:30 am 5