Value for Medical Products Consortium

Value for Medical Products Consortium


Overview

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 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; by addressing operational challenges such as fragmented and difficult-to-track patient outcome data; identifying strategies to better align RWE development for multiple purposes; and exploring the role of evidence in informing coverage policies. 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.

 

Background on the Issue

Duke-Margolis has produced a white paper to provide background on value-based reimbursement for medical products, which can be downloaded.

Value Based Payment Background Paper

 

Working Groups

 

Advancing Medical Product Value Through Legal and Regulatory Change

Description

The legal and regulatory working group of the Duke-Margolis Center for Health Policy, working with a broad-based Consortium— composed of patient advocates, payers, manufacturers, and providers, as well as experts on regulatory affairs, law, and policy — analyzes the legal barriers to meaningful VBP arrangements involving medical products, noting situations where stakeholders may be able to utilize the existing and emerging regulatory environment to develop and implement VBP arrangements.

Publications

Overcoming Legal and Regulatory Hurdles to VBP Arrangements for Medical Products

Clarifying MBP Regulations in the Context of VBP Arrangements

Comment Letters

Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals (April 2019)

Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations (December 2019)

Establishing Minimum Standards in Medicaid Drug Utilization Review (DUR) and Supporting Value-Based Purchasing for Drugs Covered in Medicaid (Collaboration with Implementation workgroup-July 2020)

Request for Information on Physician Self-Referral, Anti-Kickback, and Medicaid Best Prices Statues (January 2021)

Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing for Drugs Covered in Medicaid; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement (Collaboration with Implementation workgroup-June 2021)

 

 

Implementing Approaches to Increase the Value and Access to Novel Technologies

Description

The focus of this workgroup is to research and evaluate approaches to increase the value and access to novel medical products through different types of payment arrangements, such as value-based, condition-based, and population-based arrangements. Workgroup members assess ways to increase access to screening, diagnosis, treatment, and follow-up care within these models.

Publications

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

Breakthroughs and Barriers: Advancing Gene Therapies And Curative Health Care Through Value-Based Payment Reform

Value-based arrangements may be more prevalent than assumed -

Advancing Gene Therapies And Curative Health Care Through Value-Based Payment Reform

Payment Reform for Better Value and Medical Innovation

Advancing Value-Based Payment for Transformative Therapies

Comment Letters

Establishing Minimum Standards in Medicaid Drug Utilization Review (DUR) and Supporting Value-Based Purchasing for Drugs Covered in Medicaid (Collaboration with Legal and Regulatory workgroup-July 2020)

Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing for Drugs Covered in Medicaid; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement    (Collaboration with Legal and Regulatory workgroup-June 2021)

 

Coverage and Evidence Needs for Novel Technologies. 

Description

The focus for this workgroup is to evaluate the coverage and evidence needs for novel technologies to inform payer coverage and ensure appropriate use. Workgroup members discuss strategies to align pre- and post-market evidence development, minimize data collection burdens for providers, identify opportunities to streamline the approval to coverage process, and discuss legislative avenues to advance workgroup goals.

Publications

Cures 2.0: Modernizing Access for Breakthrough Devices

Cures 2.0: Building a Modern Health Data Infrastructure

Comment Letters

Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (November 2020)

Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (April 2021)

Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (October 2021)

Proposed National Coverage Determination for Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation (July 2020)

Duke-Margolis Research Team

Mark McClellan

Mark McClellan, MD, PhD

Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty

MHL

Marianne Hamilton Lopez, PhD, MPA

Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty

Adrian Hernandez

Adrian Hernandez, MD, MHS

Vice Dean and Executive Director of the Duke Clinical Research Institute
Vice Dean for Clinical Research, School of Medicine
Margolis Exective Core Faculty

Higgins

Aparna Higgins

Senior Policy Fellow

Arti Rai

Arti K. Rai, JD

Elvin R. Latty Professor of Law
Margolis Core Faculty

morgan romine

Morgan Romine, MPA

Chief of Staff
Senior Team Member

silcox

Christina Silcox, PhD

Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty

Gillian Schmidler

Gillian Sanders Schmidler, PhD

Deputy Director, Margolis Center
Professor of Population Health Sciences, School of Medicine
Margolis Executive Core Faculty
Anti-Racism and Equity Committee Member

Corinna Sorenson

Corinna Sorenson, PhD, MHSA, MPH

Faculty Director of Undergraduate and Graduate Studies
Senior Advisor and Founding Director, Margolis Scholars Program
Assistant Professor in Population Health Sciences and Public Policy
Margolis Core Faculty
Anti-Racism and Equity Committee Member

Sreek Vemulapalli

Sreekanth Vemulapalli, MD

Assistant Professor of Medicine
Margolis Core Faculty

Advisory Group

Alan Balch, Chief Executive Officer, Patient Advocate Foundation

Alexandra Clyde, Corporate Vice President of Global Health Policy, Reimbursement and Health Economics, Medtronic

Barbara Minton, Staff Vice President, Pharma Contract Strategies, Ingenio Rx

Chuck Bucklar, Vice President, North America Commercial Operations, BioMarin

Darin Gordon, President and CEO, Gordon & Associates, LLC

Thomas Barker, Partner and Co-Chair, Healthcare Practice, Foley Hoag LLP

Sandhya Rao, Chief Medical officer and Senior Vice President Health and Medical Management, Blue Cross Blue Shield Massachusetts

Esther Krofah, Executive Director, FasterCures

Francesca Cook, Vice President, Pricing and Market Access, Regenxbio

Gregory Poulson, Senior Vice President and Chief Strategy Officer, Intermountain Healthcare

Josh Trent, Principal, Leavitt Partners

Leigh Anne Leas, Vice President and US Country Head, Health Policy, Novartis

Lewis Sandy, Executive Vice President, Clinical Advancement, UnitedHealth Group

Mary Coppage, Senior Director, Healthcare Policy, Edwards Lifesciences

Megan O'Brien, Executive Director, Center for Observational and Real World Evidence, Merck

Michael Sherman, Chief Medical Officer, Point32Health

Rekha Ramesh, Executive Director, Head of Policy, Gilead Sciences

Robert Smith, Senior Vice President, Global Gene Therapy Business, Pfizer

Sree Chaguturu, Senior Vice President, CVS Health, Chief Medical Officer, CVS Caremark, CVS-Aetna

Stevne Miller, Senior Vice President & Chief Medical Officer, Express Scripts

Surya Singh, President, Singh Healthcare Advisors

Gregory Daniel, Global Head of Public Policy, Eli Lilly & Co

Mary Bordoni, Director, Strategic Alliance Development, Bristol Myers Squibb

Jeffrey S. Guy, Vice President, Clinical Services Group, Hospital Corporation of America

 

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 Allergan, Amgen, BioMarin, bluebird bio, Boston Scientific, Editas Medicine, Edwards Lifesciences, Gilead, Medtronic, Novartis, Pfizer, REGENXBIO, Sarepta, Spark Therapeutics, and Verastem.

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.

Duke-Margolis Project Team

MHL

Marianne Hamilton Lopez, PhD, MPA

Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty

nitzan arad

Nitzan Arad

Assistant Research Director

beena

Beena Bhuiyan Khan

Assistant Research Director

ray

Rebecca (Becky) Ray

Senior Policy Analyst

Hannah Graunke Picture

Hannah Graunke, MPP

Policy Analyst

Derick Rapista Headshot

Derick Rapista

Research Assistant

Sabine Sussman Headshot

Sabine Sussman

Policy Analyst