Rules › CMS-2026-2345

Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations

Proposed rule from the Health and Human Services Department, Centers for Medicare & Medicaid Services (docket CMS-2026-2345). 139 comment letters from companies and organizations are listed below.

Agency
Health and Human Services Department, Centers for Medicare & Medicaid Services
Docket
CMS-2026-2345
Published
2026-07-16
Comments due
2026-09-14
Status
Comment period closed September 14, 2026 · no final rule found yet
Total public comments
374
Letters listed here
139

Federal Register notice ↗ · Docket on Regulations.gov ↗

Who commented, by industry

Healthcare 100 Pharma & Medical Devices 30 Law, Accounting & Consulting 4 Technology, Media & Telecom 2 Education 1 Government & Tribes 1 Other 1

Who commented

Puerto Rico College of Medical Technologists Trade or professional group Healthcare

filed 2026-09-15

Laboratory Medicine Concepts, LLC Company Healthcare

filed 2026-09-15

Karius Company Pharma & Medical Devices

filed 2026-09-15

Joint Commission Trade or professional group Healthcare

filed 2026-09-15

Connected Health Initiative Hospital or health provider Healthcare

filed 2026-09-15

America Society for Dermatologic Surgery Association Trade or professional group Healthcare

filed 2026-09-15

Momentum Consulting, LLC Company Law, Accounting & Consulting

filed 2026-09-15

Versiti Blood Health, Inc Hospital or health provider Healthcare

filed 2026-09-15

Biotheranostics, Inc., a Hologic Company Company Pharma & Medical Devices

filed 2026-09-15

Keeler Laboratory Consulting, LLC Company Healthcare

filed 2026-09-15

Quest Diagnostics Inc. Company Pharma & Medical Devices

filed as “Quest Diagnostics” · filed 2026-09-15

Association for the Advancement of Blood and Biotherapies (AABB) Trade or professional group Healthcare

filed 2026-09-15

ASM Trade or professional group Education

filed 2026-09-15

American College of Mohs Surgery Trade or professional group Healthcare

filed 2026-09-15

Reperio Health Hospital or health provider Healthcare

filed 2026-09-15

Mass Spectrometry & Advances in the Clinical Lab (MSACL) Clinical Advisory Committee - CLIA Modernization Workgroup Company Healthcare

filed 2026-09-15

Association for Pathology Informatics Trade or professional group Healthcare

filed 2026-09-15

Guardant Health Company Pharma & Medical Devices

filed 2026-09-15

Valley Children's Hospital Hospital or health provider Healthcare

filed 2026-09-15

Nebraska Medicine Hospital or health provider Healthcare

filed 2026-09-15

Association of Genetic Technologists Trade or professional group Healthcare

filed 2026-09-15

Artera Company Technology, Media & Telecom

filed 2026-09-15

College of Reproductive Biology Trade or professional group Healthcare

filed 2026-09-15

Advocate Health Hospital or health provider Healthcare

filed 2026-09-15

American Osteopathic College of Dermatology University or school Healthcare

filed 2026-09-15

Arete Biosciences, Inc. Company Pharma & Medical Devices

filed 2026-09-15

Bioeconomy ISAC Trade or professional group Pharma & Medical Devices

filed 2026-09-15

ST JOHN HOME HEALTH LLC Hospital or health provider Healthcare

filed 2026-09-15

Laboratory Medicine Concepts, LLC Company Healthcare

filed 2026-09-15

American Society for Clinical Pathology Trade or professional group Healthcare

filed 2026-09-15

American Society for Clinical Pathology Trade or professional group Healthcare

filed 2026-09-15

California Clinical Laboratory Association Trade or professional group Healthcare

filed 2026-09-15

American Society for Clinical Laboratory Science Trade or professional group Healthcare

filed 2026-09-15

BJC Health Hospital or health provider Healthcare

filed 2026-09-15

PPTA Trade or professional group Pharma & Medical Devices

filed 2026-09-15

American Association of Bioanalysts and the National Independent Laboratory Association Trade or professional group Healthcare

filed 2026-09-15

Association of Public Health Laboratories Trade or professional group Healthcare

filed 2026-09-15

Illumina, Inc. Company Pharma & Medical Devices

filed as “Illumina” · filed 2026-09-15

Mayo Clinic Hospital or health provider Healthcare

filed 2026-09-15

Abbott Company Pharma & Medical Devices

filed 2026-09-15

Kaiser Permanente Hospital or health provider Healthcare

filed 2026-09-15

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

Association for Academic Pathology Trade or professional group Healthcare

filed 2026-09-14

Coalition for 21st Century Medicine Trade or professional group Healthcare

filed 2026-09-14

Medical Electronic Sytems Company Pharma & Medical Devices

filed 2026-09-14

ResearchDx, Inc. Company Pharma & Medical Devices

filed 2026-09-14

Kurin, Inc. Company Pharma & Medical Devices

filed 2026-09-14

American Academy of Family Physicians Trade or professional group Healthcare

filed 2026-09-14

Commonwealth Diagnostics International, Inc. Company Pharma & Medical Devices

filed 2026-09-14

The University of Kansas Health System Hospital or health provider Healthcare

filed 2026-09-14

American Association for Laboratory Accreditation (A2LA) Trade or professional group Healthcare

filed 2026-09-14

American College of Medical Genetics and Genomics Trade or professional group Pharma & Medical Devices

filed 2026-09-14

South Central Regional Medical Center Hospital or health provider Healthcare

filed 2026-09-14

Federation of American Hospitals Trade or professional group Healthcare

filed 2026-09-14

Association for Molecular Pathology Trade or professional group Healthcare

filed 2026-09-14

Histology Associates inc (ACCULAB) Company Healthcare

filed 2026-09-14

American Clinical Laboratory Association Trade or professional group Healthcare

filed 2026-09-14

Danaher Corporation Company Pharma & Medical Devices

filed 2026-09-14

American Society for Clinical Pathology Board of Certification Trade or professional group Healthcare

filed 2026-09-14

Digital Pathology Association Trade or professional group Healthcare

filed 2026-09-14

AdventHealth Central Florida Division Hospital or health provider Healthcare

filed 2026-09-14

PathNet Company Healthcare

filed 2026-09-14

Laboratory Corporation of America Holdings (Labcorp) Company Healthcare

filed 2026-09-14

Ochsner Health System - Ochsner Clinic Foundation Nonprofit or advocacy group Healthcare

filed 2026-09-14

Ochsner Health System - Ochsner Clinic Foundation Nonprofit or advocacy group Healthcare

filed as “Ochsner Heath System - Ochsner Clinic Foundation” · filed 2026-09-14

City of Hope Hospital or health provider Healthcare

filed 2026-09-14

IQVIA Laboratories Company Healthcare

filed 2026-09-14

Medical Electronic Sytems Company Pharma & Medical Devices

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

American Proficiency Institute Trade or professional group Healthcare

filed 2026-09-14

Novamed Incorporated Company Pharma & Medical Devices

filed 2026-09-14

ResearchDx, Inc. Company Pharma & Medical Devices

filed as “ResearchDx, Inc” · filed 2026-09-14

ResearchDx, Inc. Company Pharma & Medical Devices

filed 2026-09-14

Cleveland Clinic Hospital or health provider Healthcare

filed 2026-09-14

ZoomCare Nonprofit or advocacy group Healthcare

filed 2026-09-14

American Society of Cytopathology Trade or professional group Healthcare

filed 2026-09-14

College of American Pathologists Trade or professional group Healthcare

filed 2026-09-14

C&C Clinical Laboratory Consulting, LLC Company Law, Accounting & Consulting

filed 2026-09-14

South Shore Laboratory Consultants, Inc. Company Law, Accounting & Consulting

filed 2026-09-14

COLA Inc. Company Healthcare

filed 2026-09-14

UnityPoint Health Hospital or health provider Healthcare

filed 2026-09-14

National Society for Histotechnology Trade or professional group Healthcare

filed 2026-09-14

National Society of Genetic Counselors Trade or professional group Pharma & Medical Devices

filed 2026-09-14

American Association of Pathologists' Assistants Trade or professional group Healthcare

filed 2026-09-14

American Society for Mohs Surgery Trade or professional group Healthcare

filed 2026-09-14

The Native Claim Firm Company Law, Accounting & Consulting

filed 2026-09-14

Inflection Medicine Hospital or health provider Healthcare

filed 2026-09-14

American Pharmacists Association Trade or professional group Healthcare

filed 2026-09-14

Association for Diagnostics & Laboratory Medicine Trade or professional group Pharma & Medical Devices

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

Moffitt Cancer Center, Pathology Nonprofit or advocacy group Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

NMS Labs Company Healthcare

filed 2026-09-14

ARUP Laboratories Company Healthcare

filed 2026-09-14

Wisconsin Diagnostic Laboratories Company Pharma & Medical Devices

filed 2026-09-14

Clinical and Laboratory Standards Institute (CLSI) Coalition or joint letter Healthcare

filed 2026-09-14

American Society for Histocompatibility & Immunogenetics (ASHI) Trade or professional group Pharma & Medical Devices

filed 2026-09-14

ResearchDx, Inc. Company Pharma & Medical Devices

filed 2026-09-14

One Path Diagnostics LLC ; Cockerell Dermatopathology Company Pharma & Medical Devices

filed 2026-09-14

BillionToOne Company Pharma & Medical Devices

filed 2026-09-03

Magnolia Medical Technologies Company Pharma & Medical Devices

filed 2026-09-03

Gemelli Biotech Corp. Company Pharma & Medical Devices

filed 2026-09-03

American Board of Dermatology (ABD) Trade or professional group Healthcare

filed 2026-09-03

Advanced Breath Diagnostics LLC DBA Cairn Diagnostics Company Pharma & Medical Devices

filed 2026-09-03

American Academy of Dermatology / Association Coalition or joint letter Healthcare

filed as “American Academy of Dermatology Association (AADA)” · filed 2026-08-31

Metabolic Solutions, LLC Company Healthcare

filed 2026-08-26

The Patient Centric Sampling Interest Group (PCSIG) Trade or professional group Healthcare

filed 2026-08-26

Pikeville Medical Center, Inc. Hospital or health provider Healthcare

filed 2026-08-26

National Accrediting Agency for Clinical Laboratory Sciences Nonprofit or advocacy group Healthcare

filed 2026-08-26

Progressive Diagnostics LLC Company Pharma & Medical Devices

filed 2026-08-20

Lighthouse Lab Services Company Healthcare

filed 2026-08-20

PATHOLOGY ASSIST-TEMP, INC. Company Healthcare

filed 2026-08-17

Inspira Health Network Hospital or health provider Healthcare

filed 2026-08-13

Revere Health Hospital or health provider Healthcare

filed 2026-08-13

Partners in Women's Healthcare Hospital or health provider Healthcare

filed 2026-08-10

Wayne Woodlands Manor Hospital or health provider Healthcare

filed 2026-08-07

Region I Office of Human Development Government or tribe Government & Tribes

filed 2026-08-05

911 Am Pm Home Health Care Hospital or health provider Healthcare

filed 2026-07-31

TechInHSR, LLC Company Technology, Media & Telecom

filed 2026-07-31

ProMedica Health System Hospital or health provider Healthcare

filed 2026-07-31

Monte Nido Company Healthcare

filed 2026-07-30

HCA Medical City Plano Hospital or health provider Healthcare

filed 2026-07-30

BV Mobile Lab Services Company Healthcare

filed 2026-07-30

Our Savior's Medical Transport, LLC Company Healthcare

filed 2026-07-30

Apex Home Health Agency LLC Hospital or health provider Healthcare

filed 2026-07-30

Dynasty Home Health LLC Hospital or health provider Healthcare

filed 2026-07-30

American Womens Service Hospital or health provider Healthcare

filed 2026-07-30

Lab Connections Company Healthcare

filed 2026-07-30

Health Empowerment Network of Maryland, Inc. Nonprofit or advocacy group Healthcare

filed 2026-07-30

Univerisity University or school Other

filed 2026-07-30

Quality Choice Healthcare Solutions LLC Hospital or health provider Healthcare

filed 2026-07-30

Queenyee Family Medicine Clinic Hospital or health provider Healthcare

filed 2026-07-30