Vital Voices: Building Capacity for Patient Engagement with CMS

Objective: Build foundational knowledge of CMS programs, organizational structure, coverage pathways, and payment systems to support informed and effective patient engagement.

1. Overview of CMS programs

   CMS is the federal agency that provides health coverage to more than 160 million Americans through:

   1. Medicare: This is a federal program for older adults and certain individuals with qualifying disabilities.
   2. Medicaid: This is a joint federal-state program for qualifying low-income populations.
   3. Children’s Health Insurance Program (CHIP): This is a joint federal-state program for children in families above Medicaid eligibility thresholds.
   4. Health Insurance Marketplace: This consists of subsidized private plans under the Affordable Care Act.
       
2. CMS organizational structure
   1. CMS Organizational Chart: This chart shows divisions responsible for coverage, payment, and innovation.
      1. Overview of Key CMS Groups: These groups are involved in policy, coding, and payment processes: Medicare, Medicaid, CHIP, CMS Innovation Center (CMMI), The Center for Clinical Standards and Quality (CCSQ)
          
3. Medicare overview
   1. Parts of Medicare:
      1. Part A (inpatient/hospital insurance) covers inpatient hospital care, skilled nursing facility care, hospice care, and home health care.
      2. Part B (outpatient/medical insurance) reimburses for physician services, outpatient hospital services, laboratory tests, durable medical equipment (DME), medical devices, and drugs or biologicals administered by a health-care provider. 
      3. Part C (Medicare Advantage) consists of private plans that cover Parts A and B (and usually Part D) with additional benefits.
      4. Part D (prescription insurance) covers self-administered outpatient prescription drugs through a network of private plans.
   2. Payment and reimbursement basics:
      1. Part A is determined by diagnosis-related groups (DRGs): Hospitals are paid a fixed amount per discharge based on the patient’s DRG; this is called the Inpatient Prospective Payment System.
      2. Part B is determined by the physician fee schedule or the hospital Outpatient Prospective Payment System (OPPS), where providers are reimbursed based on relative value units; hospitals are paid under OPPS for facility services.
      3. Part C is determined by private plans via formulary.
      4. Part D is determined by plan formularies with tiered cost sharing.
          
   3. Resources:
      1. Video: What is covered by Parts A, B, C, and D of Medicare?
      2. Medicare & You: This handbook references information about medical benefits, costs, rights, and protections; health and drug plans; and FAQs.
      3. CMS Medicare Learning Network (MLN): Medicare Payment Systems explains how each service-type payment system works.
      4. Medicare Severity Diagnosis-Related Groups (MS-DRGs) Classificationsprovide background on how MS‑DRGs determine inpatient Medicare payments.
      5. Formulary guidance for Parts C and D
      6. Contact Medicare
          
4. Medicaid and CHIP overview
   1. State-administered programs operating with federal guidelines
   2. Coverage varies by state (benefits, eligibility, and payment models)
   3. Waivers allow states flexibility in coverage or payment
   4. Resources:
      1. Medicaid state overviews
          
5. Health Insurance Marketplace overview
   1.  CMS oversees the federal Marketplace (HealthCare.gov), including plan certification, consumer assistance, and enrollment operations. 
   2. Marketplace plans are offered by private insurers but must meet federal standards for benefits, cost sharing, and network adequacy.
      1. Resources: 
         1. Guide to the Health Insurance Marketplace
             

6. Overview of CMS Coverage Determinations

   Medicare covers items and services specifically required by law or by mechanisms such as National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), rulemaking, and claim-by-claim adjudication.

   1. Medically necessary standard: Medicare covers only items and services that are reasonable and necessary for diagnosis or treatment.
   2. Coverage pathways (relevant for certain items and services of Parts A and B only:
      1. NCDs: These are nationwide determinations by CMS of whether Medicare will pay for a certain item or service.
         1. How to request
         2. NCD process
         3. Formal process outlined in Federal Register notice
      2. LCDs: These are determinations made by Regional Medicare Administrative Contractors (MACs) regarding coverage within their respective jurisdictions.
         1. CMS LCD Process Modernization Q&A
   3. Appeals process: A formal mechanism for beneficiaries or providers to challenge coverage or payment decisions. Applies to Medicare Parts A–D, coverage denials, payment disputes, and drug coverage issues under Part D (e.g., formulary exclusions, step therapy, prior authorization)
      1. Medicare appeals overview
          

7. CMMI

   Tests and evaluates innovative payment and delivery models that directly influence how care is delivered, coordinated, and paid for, affecting patient access, quality, and affordability.

   1. Role of the CMMI
      1. Examples of CMMI models: Accountable Care Organizations (ACOs), bundled payments
          

8. Other Value-Based Payment Models

   These models tie reimbursement to the quality and effectiveness of care rather than the volume of services.

   1. Alternative Payment Models (APMs): CMS’s structured value-based models that link payment to quality and outcomes (e.g., pay-for-performance, shared savings, bundled payments, capitated care).
      1. How APMs are developed
      2. Learn more about models in your state

Objective: Understand where patients can provide input to CMS to influence coverage, quality measures, and policy development.

1. Public Comment Periods

   For coverage and rulemaking processes, CMS uses public comment periods to solicit feedback from patients and patient organizations, clinicians, and others. Many of these opportunities are led by the Center for Medicare (CM), which oversees Medicare benefits, coverage policy, and payment systems. CM explicitly encourages patients to share their experiences and perspectives.

   1. Engagement opportunities: NCD and LCD proposals; updates to Medicare Physician Fee Schedule; Hospital OPPS; rulemaking; guidance; and policy proposals
      1. Submit evidence, patient-experience data, and impact statements; coordinate community or coalition response
   2. Typical duration: 30–60 days (may vary by rule or regulatory requirement)
   3. Why it matters to patients: Public comments help CMS understand how proposed changes affect people’s access to care, costs, treatment experience, and unmet needs.
   4. Resources: 
      1. Proposed NCD public comment opportunities
      2. Current public comment opportunities for quality measures
          

2. Improving Care Access and Efficiency: CMS Office of Healthcare Experience and Interoperability (OHEI)

   OHEI incorporates human-centered design to ensure patient perspectives guide program development.

   1. Examples of OHEI engagement:
      1. OHEI human-centered design initiatives 
      2. oral health human-centered design customer engagement
      3. behavioral health human-centered design customer engagement
   2. Engagement opportunities: listening sessions, interviews, usability testing, and journey mapping.
   3. Why it matters to patients: These activities shape how CMS designs benefits, tools, and processes, helping ensure that data flow securely and easily to support the care journey. 
       

3. Quality Measures

   CCSQ oversees quality standards, patient safety, survey and certification, and development of quality measures across Medicare and Medicaid. The Measures Management System oversees the full life cycle of developing and maintaining quality measures at CMS. 

   1. Engagement opportunities:
      1. Technical expert panels
      2. Public comment periods
      3. Call for measures
      4. Focus groups and working groups
   2. Why it matters to patients: Quality measures shape how providers are evaluated, affecting the safety, equity, and consistency of care patients receive.
       

4. Advisory Councils and Medicaid Engagement

   CMS and state Medicaid programs convene advisory bodies to incorporate beneficiary perspectives.

   1. Examples:
      1. Medicaid Advisory Committees (MACs)
      2. Beneficiary Advisory Councils (BACs)
   2. Engagement opportunities: Provide feedback on policy, program design, coverage priorities
   3. Why it matters to patients: MACs and BACs are mandated platforms for individuals with lived experience to directly influence Medicaid policy and hold states accountable for effective services. 
   4. Resources: 
      1. Policy cheat sheet: New Federal Rules for MACs and BACs
      2. CMS MAC and BAC toolkit
      3. To join a MAC or BAC, check your state’s Medicaid website for recruitment announcements or contact your state agency directly.
          

5. Medicaid Section 1115 Demonstration Waivers

   Section 1115 waivers allow states to test new delivery system reforms, expand or modify benefits, pilot social‑needs-related services, or redesign cost-sharing and eligibility structures.

   1. Engagement opportunities:
      1. Federal 30‑day public comment periods for new waivers and renewals
      2. Required state-level public hearings
      3. Submission of patient experience data or coalition responses
   2. Why it matters to patients: Section 1115 waivers can significantly impact access to care (i.e., community-based behavioral health models, housing support, or changes to cost sharing). Patient voices often directly shape CMS approval decisions and state design choices.
   3. Resources: 
      1. Application process 
      2. How 1115 waivers work
          

6. Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) 

   The panel meets in a public forum approximately four to eight times during the life of the committee to review clinical evidence and advise CMS on coverage decisions.

   1. Engagement opportunities: Provide public testimony, submit written comments and evidence, highlight unmet needs or patient-centered outcomes
   2. Why it matters to patients: MEDCAC recommendations can influence CMS decisions on new technologies, diagnostics, and services.
   3. Resource: Guidance for the Public, Industry, and CMS Staff: This resource outlines the factors CMS considers when referring topics to the Medicare Evidence Development and Coverage Advisory Committee.
       
7. Other Advisory Bodies
   1. Medicare Payment Advisory Commission (MedPAC): This commission meets publicly to discuss policy issues and to formulate and vote on recommendations to Congress on Medicare payment policies.
      1. Engagement opportunities:
         1. Submit public comment letters
         2. Attend or observe public meetings
      2. Why it matters to patients: MedPAC’s recommendations influence Medicare reimbursement and benefit design, ultimately affecting access, affordability, and service availability.
      3. Resource: View upcoming meetings.
          

8. Medicare Beneficiary Ombudsman (MBO)

   This role was created to help Medicare beneficiaries understand their rights and protections, assist with grievances, appeals, and requests for information

   1. Engagement opportunities:
      1. Submit complaints or inquiries to the MBO
   2. Why it matters to patients: It provides an independent, beneficiary‑focused resource that helps resolve Medicare problems, protect rights, and elevate systemic issues that affect access to care.
   3. Resource: 
      1. Medicare complaint form
          

9. Medicare Drug Price Negotiation Program (MDPNP) 

   Provides Medicare the ability to directly negotiate the prices of certain high-expenditure, single-source Part B and D drugs without generic or biosimilar competition.

   1. Engagement opportunities: 
      1. Listening sessions
      2. Public meetings
      3. Requests for Information (RFIs)
      4. Roundtable events 
      5. Stakeholder data submissions during the manufacturer submission window
      6. Submitting feedback through the Drug Price Negotiation Information Collection Request (ICR)
      7. Public comment on CMS guidance and future rulemaking
   2. Why it matters to patients: Patient insights help CMS identify meaningful outcomes, treatment burdens, and real‑world needs that should inform drug pricing and access decisions
   3. Resources:
      1. Public engagement events
      2. RFI example: “Make Your Voice Heard” RFI summary
      3. How to submit the public submission form for reporting evidence about selected drugs and their therapeutic alternatives
      4. MDPNP guidance and policy documents
      5. Drug Price Negotiation ICR
      6. Email [email protected] using the subject line “Public Engagement” with questions
          

10. State-Level Entities

    Although not CMS-run, these bodies significantly affect patient access and affordability.

    1. Prescription Drug Affordability Boards (PDABs): State‑established bodies that review high‑cost drugs and may recommend upper payment limits.
       1. Engagement opportunities:
          1. Submit written comments during drug review processes.
          2. Provide patient testimony at public meetings.
          3. Participate in affordability review case studies or listening sessions.
          4. Engage through coalitions working on state affordability policy.
       2. Why it matters to patients: PDAB recommendations can directly influence the maximum price a state allows payers to reimburse for medications, affecting affordability, adherence, and access. 
       3. Resources:
          1. NASHP Prescription Drug Affordability Board toolkit
          2. State PDAB Program Pages: Maryland PDAB, Washington PDAB, Minnesota PDAB
    2. Drug Utilization Review (DUR) Boards & Pharmacy and Therapeutics (P&T) Committees: State Medicaid DUR Boards and P&T committees influence utilization management policies, preferred drug lists (PDLs), and safety protocols.
       1. Engagement opportunities:
          1. Provide testimony at public meetings.
          2. Submit comments on PDL updates or prior authorization (PA) changes.
          3. Participate during review of new drug classes or high‑impact therapies.
       2. Why it matters to patients: These bodies make decisions that directly affect medication access, determining PA requirements, preferred drugs, safety edits, and exception pathways.
       3. Resources:
          1. CMS DUR Guidance
          2. DUR boards and P&T committees by state (EveryLife Foundation)
              
11. Additional Resources
    1. CMS contacts database identifies relevant CMS staff and points of contact.
    2. Subscribe to the CMS coverage email updates to receive notifications about NCDs, LCDs, comment periods, and rulemaking.

Objective: Use workshops, webinars, and training to prepare your team to engage effectively.

1. CMS-Provided Training 
   1. MLN is the official source of information for Medicare fee-for-service providers on coverage, billing, and payment policies.  
   2. CMS Person and Family Engagement Strategy outlines CMS’s approach to embedding patient and family voices in care design, delivery, and evaluation.
   3. ACO Beneficiary Engagement Toolkit offers practical guidance on incorporating the patient voice into value-based care models.
       
2. FasterCures-Led Workshops and Webinars
   1. Vital Voices Workshop: Opportunities for Patient Organizations to Engage CMS
   2. Webinar Series Part 1 Strength in Numbers: Coalitions Amplifying Patient Voices
   3. Webinar Series Part 2: Patient Organization Strategies to Inform CMS Access and Coverage Decisions
   4. Vital Voices Webinar Series Part 3: Where the Rubber Meets the Road: Navigating State-Level Coverage and Payment Decisions
       
3. Rare Disease Advocacy Training
   1. Little Hercules Foundation’s Rare Access & Coverage Education (RACE) Program aims to train rare disease advocacy organizations (especially those with cell/gene therapies approved or in the pipeline) to support patient access to therapies and equipment, share knowledge on coverage and access barriers, and collectively monitor payer responses to high-cost, low-utilization treatments.
   2. The EveryLife Foundation’s Rare Advocacy Learning is a free six-week seminar series for advocates with prior advocacy experience focused on health insurance coverage, disability rights and protections, and impact communication skills.
   3. NORD’s Rare Disease Drug Development Series: What Patients and Advocates Need to Know Part 2: Navigating Drug Review and Access helps advocates understand drug development and access, and how they can play a role.
   4. NORD’s Rare Disease Advisory Councils are state-level advisory bodies focused on rare disease issues.
   5. BIO’s Access-Focused Webinar Series provides ongoing education on patient access, drug pricing policy, coverage barriers, and CMS engagement.
   6. Sick Cell’s Advancing Stakeholder Engagement with Medicaid outlines approaches to ensuring patient voices are reflected and prioritized in Medicaid coverage decisions.
       
4. Evidence-Building, Value Assessment, and HTA Engagement Resources
   1. Institute for Clinical and Economic Review (ICER) Patient Engagement is the official hub for patients and patient organizations, providing guidance on participating in ICER value assessments, submitting patient experience data, engaging in public meetings, and understanding ICER’s role in health technology assessment (HTA).
   2. Innovation and Value Initiative develops open‑source, patient‑centered value assessment models and provides structured opportunities for patients to shape how value is defined and measured.

Objective: Learn from other organizations’ experiences; use templates and examples to plan your engagement.

1. Coalition Case Studies
   1. Independence Through Enhancement of Medicare and Medicaid (ITEM) Coalition advocates for enhanced access to assistive devices, technologies, and related services. ITEM successfully advocated for Medicare to provide coverage for seat elevation and standing systems in power wheelchairs. 
      1. See their process.
   2. EACH/PIC Coalition ensures drug affordability policies (PDABs, CMS IRA programs) reflect patient-defined affordability, focusing on out-of-pocket costs and barriers to access. Utilized patient surveys and submitted comment letters
      1. EACH/PIC Coalition example comment letters
   3. MAPRx Coalition advocates for patient-centered implementation of Medicare Part D and the MDPNP through coordinated comment letters urging CMS to protect access, gather patient experience data, and strengthen communication. 
      1. MAPRx example comment letters
   4. Partnership to Improve Patient Care (PIPC) organizes efforts to engage CMS on topics such as MDPNP, PDABs, QALY transparency, etc.
      1. PIPC comment letter on the third cycle of the MDPNP
      2. PIPC recommendation letter for enhancing CMS’s Patient Engagement Strategies
          
2. Other Case Studies
   1. National Health Council’s Patient Engagement Compensation and Contracting Toolboxprovides tools and best-practice guidance to help patient organizations strengthen “meaningful patient engagement” across CMS programs, especially the MDPNP.
      1. NHC’s comments on the Medicare Drug Price Negotiation Program
   2. Alzheimer's Association helped drive the creation of the CMS GUIDE Model by long advocating for coordinated dementia care and working with CMS and bipartisan congressional leaders to advance the policy framework
      1. Dementia Care Management Framework
      2. CMS GUIDE (Guiding an Improved Dementia Experience) Model
   3. Breakthrough T1D actively submits comment letters to CMS advocating for improved access, affordability, and coverage of type 1 diabetes technologies and insulin.
      1. Implantable Continuous Glucose Monitor Comment Letter and CMS Response
   4. National Psoriasis Foundation (NPF) provided comments to ICER on its assessment of targeted immunomodulators
      1. Comment letter
      2. ICER commentary on NPF’s involvement