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Regulatory
FDA takes action aimed at helping to ensure the safety and effectiveness of laboratory developed tests
LABline
May 2, 2024
On May 14, 2024, the FDA will host a webinar to provide an overview of the final rule and phaseout policy.
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Regulatory
Dear API Abby
Danielle Casey, MBA, MLS(ASCP)CM
April 22, 2024
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Regulatory
Medicare program; Meeting announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
LABline
April 18, 2024
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Regulatory
Final Rule- CLIA Fees, histocompatibility, personnel, and alternative sanctions for Certificate of Waiver laboratories (CMS-3326-F)
LABline
April 16, 2024
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Regulatory
Recent prosecutions of clinical labs for fraud: Practices to avoid
Shelley Slade, Esq
April 12, 2024
Courtesy of CLSI
Regulatory
The Clinical and Laboratory Standards Institute announces the publication of new antimicrobial susceptibility testing documents CLSI M100-Ed34, M02-Ed14, and M07-Ed12
LABline
April 11, 2024
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Regulatory
New updated CLSI AST guidance
LABline
March 26, 2024
Important guidance just released.
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Regulatory
Announcement of the re-approval of COLA under the Clinical Laboratory Improvement Amendments of 1988
LABline
March 8, 2024
A Notice by the Centers for Medicare & Medicaid Services.
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Regulatory
Meeting of the Clinical Laboratory Improvement Advisory Committee
LABline
March 5, 2024
Notice of meeting.
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Regulatory
CMS releases vaccine toolkit of vaccine coverage and administration for Medicaid and Children’s Health Insurance Program individuals
LABline
Feb. 26, 2024
CMS summary.
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Regulatory
HHS Office for Civil Rights delivers annual Reports to Congress on HIPAA compliance and breaches of unsecured protected health information
LABline
Feb. 23, 2024
Reports highlight for regulated entities where to focus HIPAA compliance efforts.
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Regulatory
CMS issues additional guidance on program to allow people with Medicare to pay out-of-pocket prescription drug costs in monthly payments
LABline
Feb. 20, 2024
The Inflation Reduction Act’s Medicare Prescription Payment Plan will allow people to pay Medicare Part D out-of-pocket costs over the course of the year starting in 2025.
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Regulatory
Medicare program; Strengthening oversight of accrediting organizations (AOs) and preventing AO conflict of interest, and related provisions
LABline
Feb. 15, 2024
This document has a comment period that ends in 60 days.
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Regulatory
HHS releases 2023 update to Equity Action Plan
LABline
Feb. 14, 2024
Outlines new commitments to advance equity.
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Regulatory
Accrediting organization proposed rule fact sheet
LABline
Feb. 13, 2024
Strengthening CMS oversight of accrediting organizations.
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Regulatory
HHS expands TEFCA by adding two additional QHINs
LABline
Feb. 13, 2024
Seven QHINs will now safely and securely exchange critical health information for patient care.
Regulatory
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Regulatory
Texting of Patient Information and Orders for Hospitals and CAHs
LABline
Feb. 9, 2024
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Regulatory
HHS finalizes new provisions to enhance integrated care and confidentiality for patients with substance use conditions
LABline
Feb. 9, 2024
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Regulatory
HRSA takes new steps to transform the organ transplant system
LABline
Feb. 6, 2024
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Regulatory
34th edition of Standards for Blood Banks and Transfusion Services takes effect April 1
LABline
Feb. 5, 2024
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Regulatory
CMS releases proposed payment updates for 2025 Medicare Advantage and Part D programs
LABline
Feb. 2, 2024
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Regulatory
FDA and CMS: Americans deserve accurate and reliable diagnostic tests, wherever they are made
LABline
Jan. 19, 2024
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Regulatory
HHS launches new Medicaid/CHIP resource hub to help keep people covered
LABline
Jan. 16, 2024
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