Rules › CMS-2025-1888

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

Proposed rule from the Health and Human Services Department, Centers for Medicare & Medicaid Services (docket CMS-2025-1888). 142 comment letters from companies and organizations are listed below.

Agency: Health and Human Services Department, Centers for Medicare & Medicaid Services
Docket: CMS-2025-1888
Published: 2025-12-23
Comments due: 2026-02-23
Status: Comment period closed February 23, 2026 · no final rule found yet
Total public comments: 20,198
Letters listed here: 142

Federal Register notice ↗ · Docket on Regulations.gov ↗

Who commented, by industry

Healthcare 58 Pharma & Medical Devices 53 Advocacy & Nonprofits 20 Business Groups & Chambers 3 Insurance 2 Education 2 Law, Accounting & Consulting 2 Technology, Media & Telecom 1 Manufacturing & Chemicals 1

Who commented

The Save Rare Treatments Task Force (convened by Leavitt Partners) Company Pharma & Medical Devices

filed 2026-02-25

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

Who commented, by industry

Who commented

The Save Rare Treatments Task Force (convened by Leavitt Partners) Company Pharma & Medical Devices

Alivia Health Hospital or health provider Healthcare

Immune Deficiency Foundation Nonprofit or advocacy group Healthcare

American Academy of Allergy Asthma and Immunology Trade or professional group Healthcare

RetireSafe Nonprofit or advocacy group Advocacy & Nonprofits

Shionogi Inc. Company Pharma & Medical Devices

Cystic Fibrosis Foundation Nonprofit or advocacy group Healthcare

Arnold Ventures, LLC Company Advocacy & Nonprofits

Conservatives for Property Rights Nonprofit or advocacy group Advocacy & Nonprofits

Grifols Company Pharma & Medical Devices

National Organization of Rheumatology Management Trade or professional group Healthcare

We Work For Health Hospital or health provider Healthcare

SK Life Science, Inc. Company Pharma & Medical Devices

Chronic Care Policy Alliance Trade or professional group Healthcare

American Plasma Users Coalition Trade or professional group Healthcare

Patients For Affordable Drugs Nonprofit or advocacy group Healthcare

America First Policy Institute Nonprofit or advocacy group Advocacy & Nonprofits

Point32Health Company Insurance

Small Business & Entrepreneurship Council Trade or professional group Business Groups & Chambers

National Home Infusion Association (NHIA) Trade or professional group Healthcare

Bristol Myers Squibb Company Pharma & Medical Devices

Partnership to Improve Patient Care Nonprofit or advocacy group Healthcare

U.S. Pharmacopeia Nonprofit or advocacy group Pharma & Medical Devices

Biocom Trade or professional group Pharma & Medical Devices

California Life Sciences (CLS) Trade or professional group Pharma & Medical Devices

Committee for Justice Nonprofit or advocacy group Advocacy & Nonprofits

Phathom Pharmaceuticals, Inc. Company Pharma & Medical Devices

Mental Health America Hospital or health provider Healthcare

Program On Regulation, Therapeutics, And Law (PORTAL) University or school Education

AstraZeneca Company Pharma & Medical Devices

Center for Innovation and Free Enterprise Nonprofit or advocacy group Advocacy & Nonprofits

Massachusetts Biotechnology Council (MassBio) Trade or professional group Pharma & Medical Devices

Information Technology and Innovation Foundation (ITIF) Nonprofit or advocacy group Technology, Media & Telecom

Duke-Margolis Institute for Health Policy Trade or professional group Healthcare

Midsized Biotech Alliance of America Trade or professional group Pharma & Medical Devices

Protecting Innovation in Rare Cancer (PIRC) Coalition and sign-on rare disease advocacy organizations Trade or professional group Healthcare

National Taxpayers Union Nonprofit or advocacy group Advocacy & Nonprofits

National Pharmaceutical Council Trade or professional group Pharma & Medical Devices

Center for Individual Freedom (CFIF) Nonprofit or advocacy group Advocacy & Nonprofits

Recordati Rare Diseases, Inc. Company Pharma & Medical Devices

Takeda Pharmaceuticals Company Pharma & Medical Devices

Crinetics Pharmaceuticals Company Pharma & Medical Devices

Healthcare Distribution Alliance Trade or professional group Healthcare

Amgen Inc. Company Pharma & Medical Devices

The ADAP Advocacy Association Trade or professional group Healthcare

Astellas Pharma US, Inc. Company Pharma & Medical Devices

AAMC Trade or professional group Healthcare

Coalition Against Socialized Medicine Trade or professional group Healthcare

Alpha-1 Foundation Nonprofit or advocacy group Healthcare

Alliance for Transparent & Affordable Prescriptions (ATAP) Action Network Trade or professional group Healthcare

Center for Medicine in the Public Interest Nonprofit or advocacy group Healthcare

American Academy of Neurology Trade or professional group Healthcare

Citizens Against Government Waste Nonprofit or advocacy group Advocacy & Nonprofits

Seniors Speak Out Nonprofit or advocacy group Advocacy & Nonprofits

Teva Pharmaceuticals Company Pharma & Medical Devices

Infusion Access Foundation Nonprofit or advocacy group Healthcare

60 Plus Association / American Association of Senior Citizens Coalition or joint letter Advocacy & Nonprofits

The Association for Accessible Medicines (AAM) Trade or professional group Pharma & Medical Devices

American Pharmacists Association Trade or professional group Healthcare

Gilead Sciences, Inc. Company Pharma & Medical Devices

Community Access National Network Nonprofit or advocacy group Healthcare

Johnson & Johnson Company Pharma & Medical Devices

UnitedHealth Group Company Insurance

Catalyst Pharmaceuticals Company Pharma & Medical Devices

Ensuring Access through Collaborative Health / Patient Inclusion Council (EACH/PIC) Trade or professional group Healthcare

Merck Company Pharma & Medical Devices

Institute for Liberty Nonprofit or advocacy group Advocacy & Nonprofits

Pharmaceutical Research and Manufacturers of America (PhRMA) Trade or professional group Pharma & Medical Devices

Public Citizen Nonprofit or advocacy group Advocacy & Nonprofits

Genentech Company Pharma & Medical Devices

Eli Lilly and Company Company Pharma & Medical Devices

HIV+Hepatitis Policy Institute Trade or professional group Healthcare

National Home Infusion Association (NHIA) Trade or professional group Healthcare

Sumitomo Pharma America, Inc. Company Pharma & Medical Devices

Corcept Therapeutics Inc. Company Pharma & Medical Devices

Hyman, Phelps & McNamara, P.C. Company Law, Accounting & Consulting

ISPOR Trade or professional group Healthcare