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 Workgroups

The Value for Medical Products Consortium is centered on the following activity groups for the 2025 Consortium year:

Legal and Regulatory Reform
Coverage and Payment for Digital Health Technologies
Population-based Payment Models
Coverage and Evidence Needs 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 on CMS Proposed Coverage Decision for Transcatheter Tricuspid Valve Replacement (TTVR), January 2025

Comment Letter on CMS Proposed Guidance Document: Studies Protocols that Use Real-world Data, March 2025

Comment Letter on Proposed Transitional Coverage for Emerging Technologies (TCET) Notice, August 2023

Comment Letter on Proposed Guidance for Clinical Endpoints: Knee Osteoarthritis

Comment Letter on Proposed Updated Coverage with Evidence Development Guidance, August 2023

Comment Letter to CMS on IRA Price Negotiation Initial Guidance, April 2023

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, September 2019

HSS Comment Letter on Proposed Rebate Rule, April 2019

Policy and Issue Briefs: Medicare Drug Price Negotiations: Policy Implications Of The First 10 Drug's Features

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

Building Value into Reimbursement for Prescription Digital Therapeutics

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

Experiences and Interest in Value-Based Payment Arrangements for Medical Products Among Medicaid Agencies: An Exploratory Analysis

Value for Medical Products Advisory Group

Alan Balch

Chief Executive Officer, Patient Advocate Foundation

Jeffrey Guy

Vice President, Clinical Services Group, HCA Healthcare

Amy Bassano

Managing Director, Medicare, Health Management Associates

Josh Trent

Principal, Leavitt Partners

C. Bernie Good

Director, Center for Value-Based Pharmacy Initiatives, UPMC

June Cha

Policy Director, Milken Institute

Darin Gordon

Founding Partner, Speire Healthcare Strategies

Ken Cohen

Executive Director of Translational Research, Optum

Ellen Lukens

Deputy Director, Center for Medicare and Medicaid Innovation, CMS

Lee Fleisher

Principal, Rubrum Advising & Visiting Fellow, Duke-Margolis Institute of Health Policy

Gail Ryan

Director, Pharmaceutical Transformation, Point32 Health

Lew Sandy

Principal, Sulu Coaching

Greg Poulsen

Senior Vice President, Intermountain Health

Manisha Dhuria

Associate Vice President, Humana

Greg Daniel

Vice President & Head of Global Public Policy, Lilly

Michael Beebe

Executive Vice President, ADVI

Harold Carter

Senior Vice President, Pharma Trade Relations, Express Scripts

Perry Bridger

Vice President, Global Value, Payer Access & Public Policy, Edwards

Rekha Ramesh

Vice President, Head of Global Policy, Government Affairs & Policy, Gilead

Sandhya Rao

Chief Medical officer & Senior Vice President, Health & Medical Management, Blue Cross Blue Shield of Massachusetts

Sreekanth Chaguturu

Executive Vice President & Chief Medical Officer, CVS Health

Surya Singh

President, Singh Health Advisors

Tanisha Carino

Partner, Brunswick Group

Thomas Barker

Partner, Co-Chair, Healthcare Practice, Foley Hoag

Tony Baruetta

Senior Vice President, Government Relations, Kaiser Permanente

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 Edwards Lifesciences, Eli Lilly and Co., and Gilead Sciences .

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 .