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Patient Access & the Inflation Reduction Act: Advocacy Toolkit

Background

The Inflation Reduction Act, or IRA, passed in 2022, gave the Centers for Medicare and Medicaid Services the authority to negotiate drug prices in Medicare for the first time.  

The aim is to lower the amount the government, through Medicare, pays for prescription drugs. But these changes may come with unintended consequences for patient access.  

These include:  

  • Reduced innovation. Many conditions don’t yet have a treatment, making innovation and the development of new medications critical for the patient community. However, research shows that IRA drug negotiation may actually slow innovation, leading to fewer new treatments for those who need them. 
  • Decreased access. Utilization management tools like prior authorization, step therapy and non-medical switching undermine optimal care for patients. Research has shown that patients may actually experience more utilization management for medications that undergo Medicare price negotiation. 

IRA and Patient Access

In January 2025, CMS announced the next 15 medications that are up for negotiation. The list includes medicines used to treat:  

  • Type 2 Diabetes 
  • Obesity 
  • COPD 
  • Tardive Dyskinesia  
  • Cancer  
  • Asthma 

CMS needs to hear from patients, providers and care partners on why these medications are important options for you – and why patients need continued access to all appropriate therapies.

What You Can Do:

1. Submit public comment.
Patients, care partners, health care providers and others can submit comment on their perspectives with the health condition selected medications treat. Specifically, CMS is seeking input on unmet medical need and impacts to specific populations. Submissions must be made by 12:00 AM PST on March 1, 2025. 
 
How to Submit a Comment: 

  • Click here: Medicare Drug Price Negotiation Program Public Submission Form 
  • Register with a valid email address
  • Check your email for access to the submission form
  • Select the drug for which you are submitting information
  • Answer the questions
    • Required Sections
      • I28: Respondent Information 
      • J: Certification of Submission of Sections
    • Optional Sections
      • Answer any relevant questions you wish – you are not required to fill out every question.  
  • Save and submit your response. CMS will not review saved responses unless they are submitted.

ARE YOU A PATIENT, CAREGIVER OR PATIENT ADVOCACY GROUP? 
Questions I36-42 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I36-42. CMS wants to hear from you on topics including:  

    • Your experience with the selected drug 
    • Your experience living with the disease treated by the medication, and the impact on your life and well-being 
    • Why the medication is valuable to you 
    • Demographic information


ARE YOU A CLINICIAN?  
Questions I43-49 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I43-49. CMS wants to hear from you on topics including: 

    • Your area of specialization 
    • Your experience with the selected drug 
    • How it fits into disease treatment 
    • Unmet medical need and how the treatment addresses that 
    • You are able to submit up to 10 tables, charts and/or graphs that support your responses. CMS asks that you include NLM style citations for declarative statements. 


ARE YOU A RESEARCHER? 
Questions I50-56 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I50-56. CMS wants to hear from you on: 

    • Relevant evidence on the patient experiences with the selected drug, along with the condition the drug treats 
    • Impact of the treatment and its alternatives on specific patient populations 
    • Comparative clinical evidence 
    • Key considerations for CMS in evaluating the drug 


ARE YOU A CONCERNED PUBLIC INDIVIDUAL? 
Questions I57-60 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I57-60. CMS wants to hear from you on: 

    • Your experience with the selected drug 
    • Any important information CMS should consider 

2. Share your story.
If you’re a patient, care partner, or patient advocacy organization, you can register to speak in a patient-focused roundtable related to your medication. These events are intended to collect patient-focused input related to the patient experience. These meetings will be held virtually, but will not be livestreamed, in
spring 2025. More information to come on how to register. 

3. Join a townhall.
Clinicians, researchers and others from the public may also register to participate in a clinically oriented virtual townhall, to be held in spring 2025. More information to come on how to register. 

Key Messages:

 1. Many of the conditions treated by these medications are serious, debilitating conditions.  

  • Many of these conditions don’t have cures.  
  • The medications that have been selected for negotiation are valuable treatment options that must remain accessible.  

 

2. Each patient needs tailored treatment. 

  • Different patients respond to treatments differently, making it critical to have multiple accessible treatment options. 
  • A one-size-fits-all approach to care will harm patients and keep them from managing their condition.  

 

3. Innovation is needed for all patients. 

  • Price negotiations could deter companies from investing in new treatments, leaving patients with fewer options for disease management and less hope of a cure.  

 

Social Media Guide:

Hashtags: #ChronicIllness #PatientAccess #IRA

Sample Posts 

  • People living with #chronicillness deserve access to the treatment they need. #PatientAccess 
  • The #IRA gives @CMSGov the ability to negotiate drug prices for Medicare patients. This could hurt people living with chronic conditions. 
  • Tell @CMSGov that the well-being of patients is not up for negotiation. #IRA 
  • Fifteen new medications for chronic conditions are included on @CMSGov’s
  • negotiation list. This move could harm patients. #IRA 

What's Next?

Chronic conditions can make it difficult for patients to complete everyday tasks and can significantly impact patients’ quality of life.  

Patients, caregivers and providers need to share their perspective to guide policy decisions that impact treatments for all patients.  

Questions? Contact Stephanie Hu at [email protected] 

Resources

Advocating for Legislation on Serious Mental Illness: A State Advocacy Toolkit
Serious Mental Illness & the Value of Adherence
Supporting Patients with Serious Mental Illness
Meeting Patients Where They Are
How Telehealth Can Help Mental Health Patients
Barriers to Mental Health Care

Blogs

State Updates

Below is a list of current legislation that supports patients with serious mental illness. 

Arizona

SB 1083                                                                                     HB 2449

Read the bill       Contact your legislator                          Read the bill       Contact your legislator


Colorado

SB 24-110 

Read the bill       Contact your legislator


Florida

SB 268                                                                                       HB 491

Read the bill       Contact your legislator                        Read the bill      Contact your legislator


Georgia

HB 1179

Read the bill       Contact your legislator


Illinois

SB 1636                                                                                       HB 2456

Read the bill       Contact your legislator                            Read the bill       Contact your legislator


Maryland

SB 990                                                                                        HB 1423

Read the bill       Contact your legislator                            Read the bill       Contact your legislator

Massachusetts

H 989                                                                                           S 631 

Read the bill       Contact your legislator                            Read the bill       Contact your legislator


New Jersey

S 1192 

Read the bill       Contact your legislator


North Carolina

HB 680 

Read the bill       Contact your legislator


Wisconsin

SB 618                                                                                          AB 654 

Read the bill       Contact your legislator                            Read the bill       Contact your legislator

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