Regulatory Deadline Board/2026-20613

Centers for Medicare & Medicaid Services · Proposed Rule

Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes

39 days left

In plain English

CMS proposes CLIA updates that would allow virtual access under a primary lab's certificate (except cytology) and digital images for gynecologic cytology proficiency testing, plus personnel and SARS-CoV-2 reporting changes.

Who it hits

Clinical labs, digital pathology vendors, remote-read networks, and lab accreditation consultants.

Agency
Centers for Medicare & Medicaid Services
Document type
Proposed Rule
Published
Oct 8, 2026
Comments close
Dec 7, 2026
Status
39 days left
Federal Register number
2026-20613
Docket
CMS-3478-P

More from Centers for Medicare & Medicaid Services