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HHS/CMS RIN: 0938-AV89 Publication ID: 2026 
Title: ●Clinical Laboratory Improvement Amendments of 1988 (CLIA) Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualification Requirements, and Other Changes (CMS-3478) 
Abstract:

This proposed rule would highlight three main areas that require modernization: 1) virtual access implementation, 2) gynecologic cytology PT, and 3) personnel qualification requirements. These updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 42 CFR 493   
Legal Authority: 42 U.S.C. 263(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2026 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Penny Keller
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, 7500 Security Blvd,
Baltimore, MD 21244
Phone:410 786-2035
Email: penny.keller@cms.hhs.gov