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2019 Roundtable Discussion

Date/Time

September 17, 2019
4-6:00 PM ET

Location

United States Institute of Peace
2301 Constitution Ave. NW
Washington, DC 20037

Contact

Sarah DiGiovine
Director of Development
202.688.2043

The 2019 Roundtable Discussion, Innovation and Aging: Novel Approaches to Treatment and Care, was held on Tuesday, September 17, 2019 at the United States Institute of Peace.

The Alliance for Aging Research hosted expert panels of U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) leadership to reflect on the progress of recently-implemented policy changes designed to improve the health of older Americans. During the panel discussions, our experts offered insights on future changes that may positively impact health care innovation.

Overview:

  • 4:00 PM: Reception
  • 4:30 PM: Roundtable #1: New Interventions and Care Delivery Models to Promote Value for Older Adult Beneficiaries
  • 5:15 PM: Roundtable #2: FDA Trends in Real-World Evidence, Digital Technology, and Medical Device Approvals, and Potential Impacts on Medical Care for Older Adults

More Information:
2019 Annual Bipartisan Congressional Awards Dinner

Roundtable #1

New Interventions and Care Delivery Models to Promote Value for Older Adult Beneficiaries

4:30 PM – 5:15 PM

As the population ages, there is a growing need for care delivery models that can provide high quality and lower-cost health care to America’s older adults. There have been innovative projects put forth by CMMI that seek to achieve these duel objectives, including demonstration projects such as the Medicare Coordinated Care Demonstration project and the Value-Based Insurance Design (VBID) model for Medicare Advantage (MA). As the health care industry’s focus shifts to population health, barriers such as transportation, food, and housing insecurity are entering the equation of what it means to be and remain healthy, independent, and mobile. New allowances by MA plan providers offer targeted supplemental benefits, such as transportation and meal delivery, that will enable older adult beneficiaries with chronic conditions to remain at home. This panel brought together HHS, Administration for Community Living, and care design thought leaders to explore how to incorporate the preferences and needs of older adults into care delivery; what these new programs can learn from the aging network which has been working for decades to help older adults remain in their homes and communities; and public policy solutions to lower out-of-pocket health care spending for older adults.

Speakers

James G. Scott (Moderator)

James G. Scott, President & CEO of Applied Policy, founded the company to apply his in-depth knowledge of federal health policy to help healthcare providers and companies succeed.  As a respected member of the Washington, D.C. health policy community, he has gained valuable experience and relationships throughout government and private industry.

Immediately prior to founding Applied Policy, Mr. Scott was responsible for obtaining optimal Medicare coding, coverage and payment for all pharmaceutical products manufactured by Hoffmann-La Roche, Inc.  While at Roche, he also worked to resolve Medicare and Medicaid reimbursement issues at the federal level and served as the company’s principal point of contact with the Centers for Medicare & Medicaid Services (CMS).

Mr. Scott served as the Senior Legislative Advisor at CMS, advising the CMS Administrator on congressional intent in implementing the Medicare Modernization Act of 2003 and engaging Members of Congress in the implementation of the Act.  Mr. Scott received agency-wide awards in 2005 for his work with Congress on the successful implementation of the new Medicare prescription drug benefit and for his work with congressional appropriators on the Fiscal Year 2006 President’s Budget request.

Prior to his service with CMS, Mr. Scott was an Assistant Counsel with the Office of the Legislative Counsel of the U.S. Senate, where he was a principal drafter of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and other Medicare legislation.  Mr. Scott and his work were recognized through the unanimous passage of a Senate Resolution and in numerous statements by Senators and Representatives printed in the Congressional Record.

Mr. Scott received a Bachelor of Science in Political Science from James Madison University in Harrisonburg, Virginia and received his Juris Doctor, Magna Cum Laude, from the Catholic University of America, Columbus School of Law, in Washington, D.C.

Mr. Scott serves on the Board of Directors of the Alliance for Aging Research, founded the Northern Virginia Health Policy Forum and is a member of the Steering Committee of the Partnership for a Healthier Alexandria.

Rhonda L. Randall, D.O.

Rhonda L. Randall, D.O., is the Chief Medical Officer of UnitedHealthcare Employer & Individual, the nation’s largest business serving the health coverage and well-being needs of nearly 28 million Americans. Dr. Randall collaborates with U.S. employers who are looking for quality, cost-effective, long-term solutions to health benefits for their employees and retirees. She also leads the clinical strategy development for these businesses to improve quality outcomes, ensure affordability and improve health and well-being. Additionally, Dr. Randall supports the clinical strategy for UnitedHealth Group through her work in the corporate office of Medical Affairs and as a senior medical advisor to the UnitedHealth Foundation.

Since 2003, she has held clinical leadership roles in many of the enterprises businesses including: care delivery, Medicaid Long-Term Care, Medicare Special Needs Plans and Medicare Supplement. Following the 2003 passage of the Medicare Modernization Act that created the Part D prescription drug program, Dr. Randall was instrumental in developing UnitedHealthcare’s first Part D plans. In 2008, Dr. Randall transitioned to UnitedHealthcare Medicare & Retirement, serving first as regional chief medical officer for the Northeast, later concurrently as vice president and national medical director of medical management as well as the deputy chief medical officer of Evercare Hospice and Palliative Care. From 2010 to 2013 she served as Chief Medical Officer for Medicare & Retirement and then as  chief Medical Officer for UHC’s Retiree Solutions and National Accounts. Dr. Randall’s leadership enabled the business to deliver unmatched clinical quality, facilitating market leadership in Group Medicare Advantage and achieving impressive 4.5 Star ratings for the businesses National PPO plans.

Dr. Randall is a fellowship-trained geriatrician and is board certified in family practice. Her background includes years of practice in hospice and palliative medicine. Dr. Randall earned a bachelor’s degree in biology from Saint Vincent College in Latrobe, PA, and was honored in 2011 as one of the college’s Alumni of Distinction. She earned her medical degree from the Philadelphia College of Osteopathic Medicine. Dr. Randall completed her internship, residency, chief residency and fellowship at Florida Hospital in Orlando. She has served as volunteer clinical faculty in geriatrics for Florida Hospital’s Residency program and Florida State University College of Medicine. Dr. Randall has published papers on stroke, Alzheimer’s disease, polypharmacy and normal pressure hydrocephalus. Dr. Randall has served on the First Coast Carrier Advisory Committee for Medicare Local Coverage Determinations. She is a two-time recipient of UnitedHealthcare’s innovation awards, some of the business’ highest honors, first in 2005 for her leadership in disaster planning and again in 2006 for her contribution to a clinical workgroup that developed new a model of care for people with advanced illness and end-of-life needs. She has been a champion for Florida’s frail elders in the public policy arena, working with policymakers to expand long-term care home and community-based services. She has also collaborated with state agencies to update regulations so seniors who are eligible for both Medicare and Medicaid can receive hospice services from the comfort of their homes instead of a nursing home. She is a member of the Florida coalition on Physicians Orders for Life-Sustaining Treatment as well as the national Coalition to Transform Advanced Care.

Dr. Randall currently serves as President of the Florida Medical Directors Association and a member of the house of delegate as well as the nominating committee for the American Medical Director’s Association. She also serves as the Chair of the Board for St. Charles Borromeo Catholic School in Orlando, FL.

Lance Robertson

Lance Robertson was appointed to serve as Assistant Secretary for Aging and ACL’s Administrator on August 11, 2017.

His vision for ACL focuses on five pillars: supporting families and caregivers, protecting rights and preventing abuse, connecting people to resources, expanding employment opportunities, and strengthening the aging and disability networks.

His leadership in the fields of aging and disability began in Oklahoma, where he served for 10 years as the Director of Aging Services within the state’s Department of Human Services. Prior to that, he spent 12 years at Oklahoma State University, where he co-founded the Gerontology Institute and served as the executive director of the nation’s largest regional gerontology association.

Asst. Sec. Robertson earned his undergraduate degree from Oklahoma State University and a master of public administration degree from the University of Central Oklahoma, and he is a veteran of the United States Army.

The Honorable Allyson Y. Schwartz

Allyson Y. Schwartz, a former member of the U.S. House of Representatives from Pennsylvania who served from 2005-2015, is a nationally recognized leader on health care issues. Throughout her professional life she has worked on issues such as affordability, primary care, coordinated care, and increased access to coverage.

Having worked as a health service executive, Schwartz was elected to the Pennsylvania State Senate in 1990, serving 14 years until her election to Congress. In the state Senate, Schwartz was the driving force behind Pennsylvania’s CHIP program, which was a model for the federal CHIP program five years later.

In Congress, Schwartz was appointed to the powerful Ways and Means committee in her second term and served as a senior member of the Budget Committee. In both capacities, Schwartz was a strong advocate for Medicare. She was the leader in Congress on physician payment reform to encourage value over volume, supported research, innovation, and use of technology to improve quality, efficiency, and contain costs.

Schwartz was instrumental in the passage of landmark health reform legislation, authoring key provisions such as the ban on pre-existing condition exclusions for children and increased access to primary care.

Schwartz serves on the Executive Advisory Board of the Leonard Davis Institute of Health Economics of the University of Pennsylvania, as well as being a member of the Advisory Board, University of Pennsylvania Wharton School “Penn Wharton Budget Model”. Schwartz is a member of the National Hospice and Palliative Care Advisory Board, participates in an advisory group to Avalere Health’s Patient-Perspective Value Framework and serves as a member of RAND’s Technical Expert Panel on the Medicare Advantage Stars Rating System, She is on the Board of Trustees, Einstein Health, Philadelphia and served as Co-Chair of the Health and Housing for Seniors Task Force of the Bipartisan Policy Center, where she also frequently participates in roundtable discussions on the future of Medicare..

Schwartz earned a B.A. from Simmons College, and a Master of Social Service from Bryn Mawr College. She is married, has two grown sons, two daughters-in-law, and a 6-year-old granddaughter.

Roundtable #2

5:15 PM – 6:00 PM

Over the past year, the Food and Drug Administration (FDA) has been pursuing an impressive agenda to update its regulatory and statutory framework to keep pace with the rapid scientific and technological changes in biotechnology. In 2018, the FDA continued to advocate for a new regulatory approach to software, released a strategic framework for the Real-World Evidence Program, and took numerous actions to modernize the 501(k)-approval pathway. This discussion with the FDA and industry focused on how some of the agency’s biggest priorities will impact older adults, including its efforts to modernize the review of medical devices, incorporating real-world data in regulatory decision-making, and the future of digital health applications.

Speakers

Sue Peschin, M.H.S. (Moderator)

Susan Peschin, M.H.S., 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.

Todd J. Brinton, M.D., F.A.C.C.

Todd J. Brinton, M.D., joined Edwards as corporate vice president, advanced technology and chief scientific officer in February 2019. Dr. Brinton has significant experience as a champion of cardiovascular innovation, as well as a strong patient focus as a practicing clinician. He has deep ties to the medical technology community as a co-founder, board member and advisor to a number of start-up companies. Dr. Brinton began his career as an engineer in the medical technology industry, ultimately becoming a director of clinical research and development, prior to enrolling in medical school. Before joining Edwards, he was clinical professor of medicine (cardiology) and adjunct professor of bioengineering at the Stanford University School of Medicine. He has been an attending interventional cardiologist at both the Stanford University Medical Center and the Palo Alto VA Medical Center. He has served as the fellowship director at the Stanford Byers Center for Biodesign since 2006 where he has worked with numerous teams on the development of new technologies. In addition, he serves as the co-director for both the graduate and executive education programs at the center. Dr. Brinton received his bachelor’s degree from the University of California, San Diego in biomedical engineering. He earned his medical degree from the Chicago Medical School, and completed his internship, residency, and fellowships in both cardiology and interventional cardiology at Stanford.

Jeff Shuren, M.D., J.D.

Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.

“Our center experts and programs help get safe and effective technology to patients and health care professionals on a daily basis,” says Dr. Shuren. “Rapid technological advances enable us to approve such innovations as a diagnostic test for the H1N1 influenza virus, an expandable prosthetic rib for children with abnormal growth conditions, and a test that can help detect ovarian cancer.”

Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan.

Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.

Dr. Shuren has served in a leadership role at FDA or on behalf of the agency on numerous initiatives, including

• reauthorization of the Medical Device User Fee Act, which dramatically shortens review times for device applications
• creation of the Sentinel Initiative, which works toward a national electronic system for monitoring medical product safety
• development of FDA’s Pandemic Influenza Preparedness Strategic Plan
• development of FDA’s Counterfeit Drug Task Force Report
• development of the Interagency Food Safety Working Report to the President
• implementation of FDA provisions of the Medicare Prescription Drug Improvement and Modernization Act
• development and implementation of the Interagency Import Safety Working Group’s Report to the President: Action Plan for Import Safety

From 1999 to 2000, Dr. Shuren served as a detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, he also was a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section where he supervised and designed clinical studies on human reasoning.

As director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, Dr. Shuren oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.

Janet Woodcock, M.D.

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
• 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.

Sponsors

The Alliance thanks and recognizes the generous sponsors of the 2019 Roundtable Discussion:

Roundtable Sponsor

Edwards Lifesciences Corporation
GlaxoSmithKline
UnitedHealth Group

Roundtable Supporter

Biotechnology Innovation Organization
Merck
Novartis Pharmaceuticals Corporation

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