Vital Voices
Overview
The Centers for Medicare and Medicaid Services (CMS) plays a pivotal role in shaping national standards for coverage, reimbursement, and value assessment—ultimately influencing patients’ access to needed therapies. Patient organizations bring unique, real-world insights that can shape CMS’s decisions on treatment access, yet many groups are unaware of how or when to effectively engage.
The FasterCures Vital Voices effort equips patient organizations with the knowledge and strategies to engage effectively with CMS and inform decisions on therapeutic access. This collection brings together resources that provide both an understanding of CMS’s structure and mandates, as well as practical strategies for building coalitions, collecting patient experience data, and navigating state-level policy. Together, these materials offer real-world insights and actionable approaches that strengthen patient organizations’ engagement with CMS and elevate the patient voice in its activities and decisions.
Vital Voices Workshop
This four-part 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.
- 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
- 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.

Part 1
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

Part 2
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

Part 3
This moderated session includes experts with CMS and health technology-assessment-related patient engagement experience.
This panel focused 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

Part 4
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
Vital Voices Webinar Series
Strength in Numbers: Coalitions Amplifying Patient VoicesPart 1
This webinar highlighted how coalitions are successfully engaging CMS across multiple decision-making pathways.
Just the Facts: Patient Experience Data to Inform CMS Decision-MakingPart 2
The session highlighted strategies for generating patient-centered evidence, developing patient experience dossiers, and compiling patient data to elevate the patient voice in payer contexts.
Where the Rubber Meets the Road: Navigating State-Level Coverage and Payment DecisionsPart 3
The third installment of the Vital Voices webinar series explored how patient organizations can navigate and inform state-level coverage and payment structures to improve treatment access.
Vital Voices
Related Articles

Vital Voices Webinar Series Part 3: Where the Rubber Meets the Road: Navigating State-Level Coverage and Payment Decisions
The third installment of the Vital Voices webinar series explored how patient organizations can navigate and inform state-level coverage and payment structures to improve treatment access. State Medicaid programs play a pivotal role in...View Webinar
Vital Voices Webinar Series Part 2: Patient Organization Strategies to Inform CMS Access and Coverage Decisions
For some patient organizations, engaging with CMS can feel unattainable due to limited resources and expertise. Participating in coalitions can help overcome these challenges by amplifying collective patient voices, aligning priorities, and...View Webinar
Bridging Gaps in Clinical Trials: Strategies for Increasing Access and Representation
Despite high levels of spending on health care in the United States—almost double that of peer high-income countries—health outcomes continue to lag across a wide range of disease conditions. The differences in the incidence, prevalence...Read Report
Vital Voices Webinar Series Part 1: Patient Organization Strategies to Inform CMS Access and Coverage Decisions
For some patient organizations, engaging with CMS can feel unattainable due to limited resources and expertise. Participating in coalitions can help overcome these challenges by amplifying collective patient voices, aligning priorities, and...View WebinarPrescription Drug User Fee Act VIII (PDUFA)
FasterCures at the Milken Institute is honored to provide our response to the Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments [FDA–2025–N–0816]. As a nonprofit, nonpartisan think tank, the Milken...Read LetterImage
Esther Krofah
Executive Vice President, Milken Institute HealthEsther Krofah is the executive vice president of Health at the Milken Institute, leading FasterCures, Public Health, the Future of Aging, and Feeding Change. A recognized expert in health policy, biomedical innovation, and clinical research, Krofah has extensive experience shaping health initiatives that unite diverse stakeholders, foster collaboration, and motivate action toward shared goals.Defining the ROI of Patient Engagement in MedTech Product Development
Learn about the value and return on investment of patient engagement in medical technology product development.View Webinar
Toward Self-Sustaining Models for Preventive Health Investments
Many types of health interventions fit the adage, “A pint of sweat saves a gallon of blood.” By engaging in preventive behaviors and consuming preventive care, the risk of future adverse events is lowered—saving both human suffering and the...Read Article
Patient Engagement in Care Delivery: Approaches by Health-Care Providers
Patient engagement is a critical component at every stage of the health care ecosystem, from drug development to care delivery.Read Report
Defining and Demonstrating the Value of Patient Engagement in Medtech Research and Product Development
In 2022, FasterCures published a report titled The Current Landscape of the Science of Patient Input, which examined the progress of patient engagement (PE) in biomedical research and identified ways to overcome ongoing challenges. Building...Read Report

AS





