Value for Medical Products Consortium

About the Consortium

Problem Statement: 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.

Our Approach: Duke-Margolis formed the Value for Medical Products Consortium (formerly the Value-Based Payment for Medical Products Consortium) in 2017 to address challenges to VBP arrangement implementation, including legal and regulatory barriers, and operational challenges to carrying out arrangements. Since its inception the Consortium has expanded its focus to include the advancement of VBPs and other alternative financing models for medical products which promote better outcomes for patients, the application of various coverage pathways for innovative technologies, and other innovative approaches for greater value.

Consortium Composition and Participation: The Value for Medical Products Consortium is composed of patient advocates, payers, manufacturers, and providers, as well as experts on regulatory affairs, law, and policy. The Consortium operates on a membership model. All organizations are expected to contribute in-kind participation at the organizational level through conference calls, expert workshops, feedback on Consortium written products, and on the Consortium’s Advisory Group. Industry partners also contribute financial support as a condition of membership. Membership entitles each member organization to name one representative to the Advisory Group and multiple representatives to ongoing projects. The Advisory Group meets twice a year in Washington, DC or other mutually convenient location, including virtual convenings when appropriate, to provide strategic support.

Consortium Activity Groups

The Value for Medical Products Consortium is centered on the following activity groups for the 2024 Consortium year:

Advancing Medical Product Value through Legal and Regulatory Change
Evaluating Coverage and Payment Pathways for Digital Health Technologies
Advancing Population-based Payment Models
Evaluating Efficient Coverage for Novel Technologies

Our Work

White Papers: Performance Measurement Strategies in Value-Based Payment Arrangements

Breakthroughs and Barriers: Advancing Value-Based Payment for Transformative Therapies

Overcoming the Legal and Regulatory Hurdles to Value-Based Payment Arrangements for Medical Products

Comment Letters: Comment Letter to CMS on IRA Price Negotiation Initial Guidance

CMS Comment Letter on Proposed Coverage Decision, February 2022

CMS Comment Letter on Proposed Coverage Pathway, October 2021

CMS Comment Letter on Medicaid Drug Rebate program, June 2021

CMS Comment Letter on Proposed Coverage Pathway, April 2021

CMS Comment Letter on Proposed Coverage Pathway, November 2020

CMS Comment Letter on Proposed Coverage Determination, July 2020

CMS Comment Letter on Value-Based Purchasing, June 2020

HHS Comment Letter on Self-Referral Regulations and Anti-Kickback Statute, December 2019

Clarifying Medicaid Best Price Regulations In the Context of Value-Based Payment Arrangements

HSS Comment Letter on Proposed Rebate Rule, April 2019

Policy and Issue Briefs: Clarifying Medicaid Best Price Regulations In the Context of Value-Based Payment Arrangements

Cures 2.0: Modernizing Access for Breakthrough Devices

Cures 2.0: Building a Modern Health Data Infrastructure

Case Studies: Coverage and Evidence Roundtables: Tricuspid Valve Interventions

Paying for Value: Improving Outcomes, Costs, and Access through a Condition-based Bundle Payment Model

Journal Articles: Paying for Value from Costly Medical Technologies: A Framework for Applying Value-Based Payment Reforms

Value-Based Arrangements May Be More Prevalent Than Assumed

Payment Reform for Better Value and Medical Innovation

Value for Medical Products Advisory Group

Alan Balch

Chief Executive Officer, Patient Advocate Foundation

Thomas Barker

Partner & Co-Chair, Healthcare Practice, Foley Hoag LLP

Molly Burich

Head of Public Policy, Otsuka Pharmaceutical Company

Sree Chaguturu

Executive Vice President & Chief Medical Officer, CVS Health

Gregory Daniel

Vice President & Head of Global Public Policy, Eli Lilly and Co.

Megan Duplanty

Vice President, Deputy General Counsel, BioMarin Pharmaceuticals

Darin Gordon

Founding Partner, Speire Healthcare Strategies

Jeffrey S. Guy

Vice President, Clinical Services Group, HCA Healthcare

Leah Kegler

Senior Vice President of Government Affairs & Head of Washington Office, Edwards Lifesciences

Esther Krofah

Executive Vice President of Health, Milken Institute

Ellen Lukens

Deputy Director, Center for Medicare and Medicaid Innovation, CMS

Megan O'Brien

Associate Vice President, Center for Observational and Real-World Evidence, Merck

Greg Poulsen

Senior Vice President, Intermountain Health

Rekha Ramesh

Vice President, US Policy, Gilead Sciences

Sandhya Rao

Chief Medical Officer and Senior Vice President, Blue Cross Blue Shield of Massachusetts

Gail Ryan

Director, Pharmaceutical Transformation, Point32 Health

Surya Singh

President, Singh Healthcare Advisors

Josh Trent

Principal, Leavitt Partners

Funding

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 BioMarin Pharmaceuticals, Edwards Lifesciences, Eli Lilly and Co., Gilead Sciences, Merck, and Otsuka Pharmaceutical Companies.

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 .