The 2017 Roundtable Discussion, held on Tuesday, September 26, 2017, at the Willard InterContinental Hotel, focused on CMS and FDA Progress on Improving Health Outcomes for Older Patients.
The U.S. Food and Drug Administration (FDA) had a transformational year in 2016. The FDA produced negotiated agreements to reauthorize the prescription drug and medical device user fee programs and Congress passed the 21st Century Cures Act (Cures). The user fee agreements included enhancements and substantial workforce investments to further integrate patient perspectives and real-world evidence into the evaluation of new medical products. Cures also included funding and authorities intended to accelerate access to new medical products by modernizing the drug and device development processes.
The Centers for Medicare & Medicaid Services (CMS) made significant strides in 2016 to advance value and outcomes based payment. CMS reached peak provider interest in delivering care through value-based initiatives established under MACRA, the Medicare Access and CHIP Reauthorization Act. These initiatives were designed to improve quality and decrease cost in Medicare by sharing risk. MACRA put the Medicare program on track to have more than half of all payments tied to a value-based model by 2018. This shift has been slower to take place in the drug and device sectors due to impediments like anti-kickback statues, however, an increasing number of medical product manufactures are exploring outcomes-driven payment agreements to help drive quality, create savings and slow cost growth.
This expert roundtable, convened by the Alliance for Aging Research, provided leaders from the FDA and CMS with the opportunity to reflect on progress their agencies have made in implementing major policy changes to improve the health of older adults and offered their insights on future changes that may positively impact healthcare innovation.
Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research. The Alliance for Aging Research is dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the NIH, FDA, AHRQ, and CDC; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers.
Since 2012, Ms. Peschin has been a driving force in the growth and success of the organization. Under her leadership, the Alliance has remained strong in these priorities and continued to build on its reputation as a forward-thinking public policy and health education organization. As president and CEO, she leads the strategic development and implementation of Alliance initiatives, as well as manages Board governance and organizational operations. As a thought leader on many aging-related issues, she has led the Alliance in efforts to: boost older adult immunization rates; increase NIH Alzheimer’s disease and aging research funding; raise awareness of geriatric cardiac issues; develop a senior patient and family caregiver network through a PCORI engagement grant; and co-organize a first-ever NIH geroscience summit. She participates in major industry and policy symposiums around the country each year, and has published opinion pieces in news outlets nationwide.
Ms. Peschin currently serves on the Board of Heart Valve Voice U.S. and the National Council on Patient Information and Education; on the World Economic Forum’s Council on Human Enhancement; on the National Advisory Council for the National Institute on Aging at the NIH; on the Steering Committee for the Coalition for Imaging & Bioengineering Research; and as a member of the Lifespan Domain Task Force for the Clinical & Translational Science Award program, funded by NCATS at the NIH.
Ms. Peschin earned a B.A. in Sociology from Brandeis University, and a M.H.S. degree in Health Policy from the Johns Hopkins University Bloomberg School of Public Health.
Janet Woodcock is the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). The center makes sure that safe and effective drugs are available to improve the health of people in the United States.
Dr. Woodcock and her center: evaluate prescription and over the counter drugs before they can be sold and oversee their testing in clinical trials; provide health care professionals and patients the information they need to use medicines wisely; ensure that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks; and take action against unapproved, contaminated, or fraudulent drugs that are marketed illegally.
“New drugs—and new uses for older drugs—save lives, reduce suffering, and improve the quality of life for millions of Americans,” says Dr. Woodcock. “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”
Dr. Woodcock has led many of FDA’s drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently.
Most recently, Dr. Woodcock launched the “Safety First” and “Safe Use” initiatives designed to improve drug safety management within and outside FDA, respectively.
Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. She also led CDER as director from 1994–2005. Prior to joining CDER, Dr. Woodcock oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis in her position as director of the Office of Therapeutics Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER).
Dr. Woodcock received her medical degree from Northwestern University Medical School, and her undergraduate degree from Bucknell University. She has held teaching appointments at Pennsylvania State University and the University of California at San Francisco. She joined FDA in 1986.
Jean D. Moody-Williams, RN, MPP, is the Deputy Director of the Center for Clinical Standards and Quality. Jean is a member of the leadership team responsible for one of CMS’ Centers that has more than 400 employees and a $3 billion annual budget. She is responsible for working with a great team to lead policy activities for Quality Improvement Programs, End Stage Renal Disease Networks, Survey and Certification, Quality Measurement and Health Assessment, Clinical Standards, Coverage and Analysis, Quality Innovations Models and many of the agency’s Value Based Purchasing and public reporting programs for hospitals, physicians and ambulatory settings.
Prior to this, she was the Group Director for the CMS Quality Improvement Group (QIG) in CMS and provided oversight for the nation’s Quality Improvement Organizations, or QIOs, and the End Stage Renal Disease Quality Networks which provide a national infrastructure to support technical assistance, learning and action networks, and a variety of value and quality improvement efforts across the entire continuum of care. She also served as the Director of Quality for CMS Medicaid Programs.
Prior to joining CMS, Ms. Moody-Williams served as an executive at a number of state and private entities working to improve care for patients and families including, the Maryland Health Care Commission (MHCC), the National Resource Center for Health Policy and Strategies, Quality Improvement Organizations and a health care system in Dallas. She is also a clinician.
She is the author of the book, Transitions, Trust and Triumph: A Daily Devotion for Caregivers. She received her Bachelors of Science in Nursing from Hampton University and a Masters of Public Policy and Management from the University of Maryland, College Park.
Derek Asay is Senior Director, Government Strategy, Federal Accounts and Quality at Lilly USA. Derek established and maintains the ongoing Lilly relationship with Centers for Medicare and Medicaid Services (CMS) across all Medicare and Medicaid business. His team is responsible for Lilly business strategy across all government segments, including Medicare, Medicaid, and 340B. He leads the implementation of health care reform legislation and regulations from the Lilly business perspective, which includes actively preparing for the 2014 Medicaid expansion and the launch of the state health insurance exchanges. Derek’s team is responsible for health care reform education, both internally with Lilly employees and externally with payer and healthcare professional customers. His team also leads all Lilly engagement with national quality organizations such as the National Quality Forum (NQF). Prior to his current role, Derek held leadership positions in brand management and payer marketing.
Prior to joining Lilly in 1999, Derek served numerous pharmaceutical sales, marketing and finance roles with Hoffmann-La Roche.
Derek holds an undergraduate degree in economics and political science from Indiana University and a Masters in Business Administration in Finance and Marketing from the Leonard N. Stern School of Business at New York University.
Crystal is the Head of Government Affairs, Advocacy and Policy for Avanir Pharmaceuticals, a subsidiary of Otsuka America Inc. She founded the government affairs and policy department at Avanir where her team is responsible for creating and maintaining relationships with CMS, HHS, Congress, State Legislatures and membership organizations; including NQF,AHRQ and PCORI.
In addition, Crystal’s team leads all patient advocacy interactions for the organization at the federal and state level and internally works to help set the company’s corporate strategies and business development. Crystal works closely with internal and external colleagues to help prepare for regulatory and legislative changes and future impacts to the healthcare industry to ensure patients continue to have access and affordability to healthcare and treatments.
Prior to working at Avanir Crystal held various leadership roles at Amylin and Pfizer. She holds an undergraduate degree from Virginia Wesleyan in Business Administration.
Susan C. Winckler is the President of Leavitt Partners Consulting and Chief Risk Management Officer of Leavitt Partners. Susan manages a robust portfolio of client engagements, individually advises clients on how to succeed in the evolving value-driven health care economy, and leads new product development to ensure clients have the latest intelligence and tools needed for strategic planning and positioning of organizational assets. She also oversees the corporate compliance program, conflict of interest procedures, and legal record management.
A pharmacist and attorney by training, Susan is the former chief of the staff for the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) and former president and CEO of the Food and Drug Law Institute, a nonprofit organization based in Washington, D.C., which provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction.
At the FDA, Susan provided integrated policy analysis and strategic consultation to the Commissioner and senior FDA officials on significant agency issues and programs, serving as the agency’s principal liaison with HHS. Ms. Winckler led the operations of the Office of Legislation (until April 2009), the Office of External Relations, Office of Public Affairs, and Office of the Executive Secretariat. She joined the FDA in September 2006 as the Director, Policy Communications, in the Office of Policy and Planning within the Office of the Commissioner, where she served as a point person for constituent communications and policy development on key issues. Immediately prior to joining the FDA, Susan served as the vice president for policy and communications and staff counsel for the American Pharmacists Association (APhA), the national professional society of pharmacists, serving as the senior lobbyist for the Association on Capitol Hill. Previous positions with the Association include group director of policy and advocacy, director of policy and legislation, director of practice affairs, and manager of special projects.
Susan is a graduate of the University of Iowa College of Pharmacy and the Georgetown University Law Center, magna cum laude. She is a Fellow of the American Pharmacists Association, a Distinguished Alumna of the University of Iowa College of Pharmacy, delivered the William A. Zellmer Lecture for the American Society of Health-System Pharmacists and named as Distinguished Young Alumna of the University of Iowa Foundation. She was elected a Trustee of the United States Pharmacopeial Convention (USP) for the 2015-2020 term, elected a Distinguished Fellow in Public Policy to the National Academies of Practice, Pharmacy Academy, and named a Woman of Distinction by Alpha Xi Delta Fraternity.