FY 2022 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program

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Title
FY 2022 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program
Memo #
QSO-25-25-AO/CLIA
Posting Date
2025-09-05
Fiscal Year
2025
Title
Memorandum Summary

Annual Report to Congress: The 2022 annual RTC details the review, validation, and oversight of the FY 2021 activities of the approved AOs Medicare accreditation programs as well as the CLIA Validation Program.
• Section 1875(b) of the Social Security Act (the Act) requires the Centers for Medicare & Medicaid Services (CMS) to submit an annual report to Congress on its oversight of national AOs and their CMS-approved accreditation programs.
• Section 353(e)(3) of the Public Health Service Act (PHSA) requires CMS to submit an annual report of the CLIA validation program results.
• The release timeline for the 2022 annual RTC was adjusted in response to COVID-19 Public Health Emergency considerations. To ensure stakeholders have access to the most current and comprehensive information available, CMS will expand the next RTC to include oversight data from 2022-2024.

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