The Centers for Medicare and Medicaid Services (CMS) is the bellwether for payers and value assessors nationwide. Patient organizations have the power to shape decisions by using the collective experiences, data, insights, and perspectives of their communities to influence R&D activities and access to medical products.

Join us for a dynamic in-person workshop that will empower patient organizations to engage effectively with CMS. Discover how to tap into existing engagement structures, hear real-world success stories, and explore innovative strategies to impact treatment access and coverage decisions.

Workshop Objectives: 

  • Provide an overview of relevant CMS offices and programs, highlighting the entities responsible for stakeholder engagement. 
  • Discuss CMS decision-making processes, including how and when they involve stakeholders, what information the agency uses for decision-making, and the role of patients/patient organizations.  
  • Highlight case studies, promising practices, and lessons learned from patient organizations engaged with CMS. 

This event is being made available to patient organizations that fund or advance biomedical research and development only. If your organization is outside that categorization and would like to attend, please contact TRAIN@milkeninstitute.org.

Program

9:00 AM - 10:00 AM Check-In and Breakfast 

10:00 AM - 10:30 AM Welcoming Remarks and Table Introductions

10:30 AM-  11:00 AM Overview of CMS Centers, Functions, and Resources for Patients

This session will provide a broad overview of CMS Centers and respective center functions. It will provide an orientation to various offices and programs supporting healthcare and medical product access at federal and state levels, including Medicare (Parts A-D), Medicaid, and the Child’s Health Insurance Program. This session will also touch on the CMS programs oriented towards hearing from the patient community or providing patient support.  

Presenter:

  • Lee Fleisher, MD, M.L, CEO, Rubrum Advising, Former Chief Medical Officer and Director of the Center for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services (CMS) from 2020-2023

11:00 AM - 11:30 AM Patient Organization Opportunities to Engage with CMS for Medical Product Access Determinations in Medicare

The presentation will cover activities that govern CMS traditional and new mandates that are most relevant to therapeutic access and coverage, including the Medicare Drug Pricing Negotiation Program, national and local coverage determination processes, prior authorization processes, new technology add-on payments, drug utilization/formulary reviews, etc.   

Presenter:

  • Kristi Martin M.A, M.P.A, Director, Camber Collective, and Former Chief of Staff and Senior Advisor to the Deputy Administrator in the Center for Medicare at the Centers for Medicare & Medicaid Services (CMS)

11:30 AM - 12:00 PM Expert Panel Discussion: Strategies for Engaging CMS

This session will include a moderated discussion of those with CMS and health technology assessment patient engagement experience and knowledge focusing on the following topics: 

  • Examples and cases regarding the need and use for more structured patient-informed data to inform coverage and the value of medical products.
  • When is the ideal time to engage in the processes.
  • Dos and Don’ts when planning to engage CMS and others to inform patient access to medical products with real-life data and stories.

Panelists:

  • Catherine Koola Fischer, Director of Patient Engagement at the Institute for Clinical and Economic Review
  • Kristi Martin M.A, M.P.A, Director, Camber Collective, Former chief of staff, and senior advisor to the deputy administrator in the Center for Medicare at CMS
  • Jean Moody-Williams RN, MPP, Former Deputy Director Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicare Services (CMS)

12:00 PM - 12:50 PM Lunch

1:00 PM - 2:15 PM Patient Organization Case Examples

Patient organizations with experience with engaging CMS will share their stories of how they engaged CMS, highlighting the purpose of the engagement, initial contact and relationship management approach, centers involved, methods and strategies employed to engage and provide input, types of information utilized, partnerships involved, challenges, lessons learned, how information was utilized, and impact of engagement/outcome. Following the series of presentations, audience Q&A will follow. 

Panelists:

  • Rich Brennan, Vice President of Government Affairs, The ALS Association
  • Jason Harris, Vice President of Government Relations & Advocacy, National Psoriasis Foundation
  • Kelly Maynard, President and Founder, Little Hercules Foundation
  • Tiffany Westrich-Robertson, CEO, Co-Founder, and Board President, AI Arthritis

2:15 PM - 3:00 PM Brainstorming your CMS Engagement Approach

During this session, we will conduct a small group discussion activity where each group will be asked to discuss potential approaches to CMS/payer engagement and reflect on where they may be able to make progress or prepare for CMS engagement.  

3:00 PM- 3:15 PM Workshop Reflections and Closing Remarks 

3:15 PM - 4:00 PM Participant Networking

4:00 PM - 4:30 PM American Dream Discovery Center Tour (Optional)

We will be hosting an optional guided tour of the American Dream Discovery Center which is set to officially open to the public on July 4th, 2025.