Amidst the broader shift from a fee-for-service (FFS) payment structure to a value-based U.S. healthcare marketplace, significant concerns have arisen over a medical product pipeline that is full of innovative - but also high-cost - therapies. These concerns have led to increased interest in developing new payment and alternative financing models for health care that strive to ensure better outcomes for the dollars spent, and thus higher value. Some limited but growing experience exists with these models, broadly referred to as Value-Based Payment (VBP) arrangements, but key regulatory, operational, and infrastructure challenges remain.
Duke-Margolis has formed a Value-Based Payment Consortium to address these challenges and to better align policies for VBP implementation. The Consortium—composed of patient advocates, payers, manufacturers, and providers, as well as experts on regulatory affairs, law, and policy—is developing approaches to payment reform that support better outcomes for patients and better value across the system. The Consortium seeks to overcome current barriers to VBP arrangements by identifying and developing solutions to legal and regulatory issues, and by addressing operational challenges such as fragmented and difficult-to-track patient outcome data. Additionally, the group will develop conceptual frameworks for structuring VBP arrangements, facilitate stakeholder input and support, and explore other novel approaches leading to greater value.
In addition to the Consortium, the Margolis Center is undertaking complimentary work to further support advancement of value based payment. These activities have included workshops dedicated to advancing payment reforms for Alzheimer’s therapies and within the oncology space, as well as a survey with the National Pharmaceutical Council to better understand the negotiation process for Value-Based Payment arrangements. Additionally, Duke-Margolis has been engaging stakeholders to develop and refine a proposal that would provide developers with a return of investment for Antimicrobial Innovation while also supporting stewardship.
Duke-Margolis has produced a white paper to provide background on value-based reimbursement for medical products, which can be downloaded.
Legal and Regulatory Issues
Duke-Margolis and members of the consortium have released a white paper providing recommendations for overcoming legal and regulatory barriers to value-based payment for medical products, which can be downloaded.
Duke-Margolis Project Team
Mark McClellan, MD, PhD
Robert J. Margolis Professor of Business, Medicine, and Policy; Director, Duke-Margolis Center for Health Policy, Duke University
Gregory Daniel, PhD, MPH
Clinical Professor, Duke Fuqua School of Business; Deputy Director, Duke-Margolis Center for Health Policy, Duke University
Marianne Hamilton Lopez, PhD, MPA
Katie Greene, MPP
Adrian Hernandez, MD
Professor of Medicine and Director, Health Services Outcomes Research, Duke Clinical Research Institute, Duke University
Arti Rai, JD
Professor of Law and Co-director, Duke Law Center for Innovation Policy, Duke University
Monika Schneider, PhD
Christina Silcox, PhD
Corinna Sorenson, PhD, MHSA, MPH
Assistant Professor of Medicine, Duke University
Juan Qian, MPP
Senior Research Assistant, Duke-Margolis Center for Health Policy, Duke University
Chief Executive Officer, Patient Advocate Foundation
Partner and Co-Chair, Healthcare Practice, Foley Hoag
Deputy Director, Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services
Former Executive Vice President, Medical Affairs, CareFirst BlueCross BlueShield
Chief Executive Officer, National Health Council
Vice President, Global Value, Payer Access and Public Policy, Edwards Lifesciences
Corporate Vice President of Global Health Policy, Reimbursement and Health Economics, Medtronic
Senior Vice President and Chief Medical Officer, Allergan
Executive Vice President and Chief Medical Officer, Hospitals, Quality and Care Delivery Excellence, Kaiser Permanente
President and CEO, Gordon & Associates, LLC
Senior Vice President, Corporate Affairs, Editas Medicine
Leigh Anne Leas
Vice President and US Country Head, Health Policy, Novartis
Chief Executive Officer, bluebird bio
Global President, Rare Disease Group, Pfizer Innovative Health, Pfizer Inc.
Co-Founder and Chief Executive Officer, Spark Therapeutics
Senior Vice President & Chief Medical Officer, Express Scripts
Senior Vice President, Global Value, Access & Policy, Amgen
Vice President, Global Health Policy, Boston Scientific
President of Clinical Services and Chief Medical Officer, Hospital Corporation of America
Dana Gelb Safran
Chief Performance Measurement and Improvement Officer/Senior Vice President, Enterprise Analytics, Blue Cross Blue Shield of Massachusetts
Executive Vice President and Chief Clinical Officer, Anthem
Executive Vice President, Clinical Advancement, UnitedHealth Group
Chief Medical Officer and Senior Vice President, Harvard Pilgrim Health Care
Corporate Vice President and Chief Medical Officer, Specialty Client Solutions, CVSHealth
Chief Risk Management Officer, Leavitt Partners/President, Leavitt Partners Consulting
This project is made possible through the generosity of the Margolis Family Foundation, which provides core resources for the Center, as well as a combination of financial and in-kind contributions from consortium members including Allergan, Amgen, bluebird bio, Boston Scientific, Editas Medicine, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Spark Therapeutics.
Participation of private or non-profit organizations in Center activities does not imply an endorsement by Duke University or associated entities. As part of Duke University, Duke-Margolis honors the tradition of academic independence on the part of its faculty and scholars. Neither Duke nor the Margolis Center take partisan positions, but the individual members are free to speak their minds and express their opinions regarding important issues. Duke Margolis adheres to all institutional policies on research independence and conflict of interest.