Vital Voices: Opportunities for Patient Organizations to Engage CMS
The Centers for Medicare and Medicaid Services (CMS) sets the standards for payers and value assessors nationwide. Patient organizations have the power to shape decisions by leveraging the collective experiences, data, insights, and perspectives of their communities to inform research and development activities and access to medical products.
This dynamic in-person workshop aimed to empower patient organizations to engage effectively with CMS. Attendees discovered how to tap into existing engagement structures, heard real-world success stories, and explored innovative strategies to inform treatment access and coverage decisions.
This toolkit contains the session video recordings and relevant resources presented during an April 2025 workshop, “Vital Voices Workshop: Opportunities for Patient Organizations to Engage CMS.” The Milken Institute is grateful to Merck for its support of the Institute’s independent work on building capacity for patient engagement with CMS.
Video 1: Welcome and Overview of CMS Centers, Functions, and Resources for Patients
This session provides a broad overview of CMS Centers and their functions. It will provide an orientation to various offices and programs supporting health care and medical product access at federal and state levels, including Medicare (Parts A–D), Medicaid, and the Children’s Health Insurance Program. The session also discusses programs designed to engage and support the patient community.
Welcome Remarks
Kristin Schneeman
Senior Director, FasterCures, Milken Institute Health
Presenter
Lee Fleisher, MD, ML
Founding Principal and CEO at Rubrum Advising, LLC; Former Chief Medical Officer and Director of the Center for Clinical Standards and Quality (CCSQ), CMS
Video 2: Patient Organization Opportunities to Engage with CMS for Medical Product Access Determinations in Medicare
This presentation covers CMS’s 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, new technology add-on payments, and drug utilization/formulary reviews.
Presenter
Kristi Martin, MA, MPA
Director, Camber Collective; Former Chief of Staff and Senior Advisor to the Deputy Administrator, CMS
Video 3: Expert Panel Discussion: Strategies for Engaging CMS
This moderated session includes experts with CMS and health technology-assessment-related patient engagement experience 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, MPH
Director of Patient Engagement, Institute for Clinical and Economic Review
Kristi Martin, MA, MPA
Director, Camber Collective; Former Chief of Staff and Senior Advisor to the Deputy Administrator, CMS
Jean Moody-Williams RN, MPP
Founder and CEO, JDMW Healthcare Advisors LLC, and Former Deputy Director, Center for Clinical Standards and Quality (CCSQ), CMS
Moderator
June Cha, PhD, MPH
Policy Director, FasterCures, Milken Institute Health
Video 4: Patient Organization Case Examples and Closing Remarks
Patient Organization Case Examples
Patient organizations share their stories of engaging 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. A Q&A session with the audience follows the presentations.
Panelists
Tiffany Westrich-Robertson
CEO, Co-Founder, and Board President, AI Arthritis
Jason Harris
Vice President of Government Relations & Advocacy, National Psoriasis Foundation
Rich Brennan, MA
Vice President of Government Affairs, The ALS Association
Moderator
Kristin Schneeman
Senior Director, FasterCures, Milken Institute Health
Closing Remarks
Raymond Puerini
Director, FasterCures, Milken Institute Health
Tools You Can Use
Workshop Resources:
CMS Resources:
- Medicare Basics | Parts of Medicare
- Medicaid Advisory Committees & Beneficiary Advisory Councils
- Public Comments | CMS
- OHEI Stakeholder Engagement | CMS
- Medicare Coverage - General Information | CMS
- CMS Organizational Chart | CMS
- Legislative-Mandates-Supplemental-Material
- Medicare Drug Price Negotiation | CMS
Additional Resources:
- 21st Century Cures Act | FDA
- How patient advocates can engage with CMS - Bio.News
- Engaging Consumers in Medicaid Program Design: Strategies from the States - PMC
- Engaging Patients in Value-Based Payment - Partnership to Improve Patient Care
- National Health Council: Medicaid Resources
- ICER: Patient Engagement Resources
- Little Hercules Foundation: Rare Access & Coverage Education
- Coalitions: MapRX, ITEM Coalition, and EACH/PIC.