Event Sponsors

Event Details

Date: Tuesday, December 5, 2023
Time: 8:30 AM – 12:30 PM ET
Location:Leavitt Partners, LLC, 601 New Jersey Ave NW, Suite 350, Washington, DC

The Innovation and Value Initiative, Alliance for Aging Research, Leavitt Partners, LLC, and the National Pharmaceutical Council are hosting a public event focused on health equity, patient engagement, and related methodological and evidence issues in CMS’ implementation of the Drug Price Negotiation Program (DPNP) as mandated by the Inflation Reduction Act (IRA).

The half-day event aims to bring together a range of perspectives, including practical on-the-ground experience and broader policy and scientific expertise, in three panel sessions. The objective is to identify critical steps that CMS, policymakers, and others could take to address equity in implementing the IRA drug price negotiations.

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Agenda

Opening remarks by Chief Executive Officer of Innovation and Value Initiative, Jason Spangler.

This level-setting conversation will draw on speakers’ expertise and first-hand knowledge of CMS’s processes and patient engagement (DPNP and otherwise), patient-centered outcomes research, FDA’s patient-focused drug development work, approaches to patient engagement in other settings int he U.S. and abroad, and other topics to explore three key questions:

  • What does equity mean in the DPNP context?
  • What can we learn from other contexts?
  • What would an equitable DPNP look like?

Speakers

  • Moderator: Jason Spangler, MD, MPH, FACPM (Innovation and Value Initiative)
  • Gary Puckrein, PhD (National Minority Quality Forum)
  • Andrea Thoumi, MPP, MSc (Duke-Margolis Center for Health Policy)

CMS has stated a commitment to prioritizing health equity and patient perspectives in its implementation of the IRA, but does the current DPNP process support that goal? Does the current process allow sufficient engagement opportunities for all—and especially disadvantaged—communities? What mechanisms currently exist to ensure their contributions carry weight in negotiations? This panel will examine the current DPNP process in terms of successes, concerns, and implications for health equity and patient engagement, and discuss potential steps to better advance health equity and ensure patient-centered decision-making throughout IRA implementation.

Speakers

  • Moderator: Omar A Escontrías, DrPH, MPH (National Health Council)
  • Michael Ward, MS (Alliance for Aging Research)
  • LCDR Ashley Channels, PharmD, BCPS (U.S. FDA)
  • Tammy Boyd, JD, MPH (American Cancer Society Cancer Action Network)

The DPNP Process allows submission of evidence for consideration by CMS in two ways: Information submission during data collection periods and subsequent patient listening sessions. What the evidence includes, who it represents, and how it is used will decide the outcomes of the process and its implications. How can CMS navigate evidence gaps and methodological challenge? What steps can or should CMS take to account for bias or lack of representation in scientific data, real world evidence, and even its own listening sessions? And beyond “specific populations,” what other communities—individuals with rare disorders, for example—may be affected by bias in the evidence used for comparative effectiveness analyses? This panel will discuss these challenges, steps CMS might take to support inclusion of patient-identified outcomes, and opportunities for CMS to engage with researchers, patient groups, and other organizations to address these issues.

Speakers

  • Moderator: Rick Chapman, PhD (Innovation and Value Initiative)
  • Jon Campbell, PhD, MS (National Pharmaceutical Council)
  • Anika Rahman (AiArthritis)

Preceding panel discussions focus on specific aspects of the DPNP process, and this panel will explore how these specific concerns and suggested solutions fit into the broader context of drug price negotiation and IRA implementation. What changes in CMS process or methodology would address concerns raised in earlier discussions—and would they have other unintended consequences? As the DPNP proceeds, how should CMS and others evaluate whether it is patient-centered and equitable? What downstream changes in innovation, research, drug development, or elsewhere are necessary, and how should CMS navigate through issues outside the agency’s influence? This panel will take up these questions and discuss concrete steps CMS, policymakers, and others can take.

Speakers

  • Moderator: Andrea Maresca, MPH (Health Management Associates)
  • Josh Trent, MS (Leavitt Partners)
  • Geni Tunsdall, JD (Academy of Managed Care Pharmacy)
  • Bryan O. Buckley, DrPH, MPH, MBA (National Committee for Quality Assurance)

Closing remarks by the Innovation and Value Initiative’s Director of Policy, Mark Linthicum, MPP.

Speakers

Tammy Boyd

American Cancer Society Cancer Action Network

Bryan Buckley

National Committee for Quality Assurance

Jon Campbell

National Pharmaceutical Council

Ashley Channels

U.S. Food and Drug Administration

Rick Chapman

Innovation and Value Initiative

Omar Escontrías 

National Health Council

Mark Linthicum

Innovation and Value Initiative

Andrea Maresca

Health Management Associates

Gary Puckrein

National Minority Quality Forum

Anika Rahman

AiArthritis

Jason Spangler

Innovation and Value Initiative

Andrea Thoumi

Duke-Margolis Center for Health Policy

Josh Trent

Leavitt Partners

Geni Tunstall

Academy of Managed Care Pharmacy

Michael Ward

Alliance for Aging Research