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Regulatory
CMS announces new procedures for receiving electronic CLIA certificates, fee coupons, and Loss of Accreditation warning letters
LABline
Nov. 27, 2023
Updates from CMS.
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Regulatory
CMS finalizes physician payment rule that advances health equity
LABline
Nov. 6, 2023
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Regulatory
HHS proposes rule to establish disincentives for healthcare providers that have committed information blocking
LABline
Oct. 30, 2023
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Regulatory
Medicare and Medicaid programs; Quarterly listing of program issuances-July through September 2023
LABline
Oct. 26, 2023
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Regulatory
Unpacking the FDA's proposed rule for LDTs
LABline
Oct. 26, 2023
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Regulatory
Medical devices; Laboratory developed tests
LABline
Oct. 4, 2023
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Regulatory
FDA launches pilot program to help further accelerate development of rare disease therapies
LABline
Oct. 3, 2023
Further accelerating the development of novel drug and biological products for rare diseases.
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Regulatory
FDA proposes rule aimed at helping to ensure safety and effectiveness of laboratory developed tests
LABline
Sept. 29, 2023
FDA update.
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Regulatory
Scientific challenges and opportunities to advance the development of individualized cellular and gene therapies; Request for information
LABline
Sept. 22, 2023
A Notice by the Food and Drug Administration on 09/21/2023.
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Regulatory
HHS Office for Civil Rights settles with L.A. Care health plan over potential HIPAA security rule violations
LABline
Sept. 12, 2023
LA Care paid $1,300,000 to settle.
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Regulatory
AABB seeks feedback on implementation of DHQ v4.0
LABline
Sept. 11, 2023
Regulatory update.
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Regulatory
Recommendations for the use of clinical data in premarket notification [510(k)] submissions
LABline
Sept. 8, 2023
Draft guidance for industry and Food and Drug Administration staff.
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Regulatory
CMS requests your input on possible updates to the CLIA regulations
LABline
Sept. 5, 2023
CMS CLIA communications update.
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Regulatory
Medicare program final rule
LABline
Aug. 30, 2023
A rule by CMS.
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Regulatory
Request for information within proposed regulations
LABline
Aug. 9, 2023
Proposed rule.
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Regulatory
‘Ask the FDA and CMS/CLIA’ annual meeting session questions due Friday
LABline
Aug. 3, 2023
Reminder.
Regulatory
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Regulatory
Request for information; Episode-based payment model
LABline
July 19, 2023
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Regulatory
EXPIRED: Release of laboratory director and tax information numbers and information contained in the ASPEN complaint/incidents tracking system
LABline
July 19, 2023
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Regulatory
CMS CLIA communications update
LABline
July 14, 2023
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Regulatory
Release of laboratory director and owner names and their taxpayer identification numbers
LABline
July 7, 2023
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Regulatory
Joint Commission no longer evaluating compliance with COVID-19 vaccination requirement
LABline
July 6, 2023
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Regulatory
AABB releases toolkit for implementation of cold-stored platelets and updates to the circular of information
LABline
July 5, 2023
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Regulatory
Announcing the physical activity guidelines midcourse report on older adults!
LABline
June 30, 2023
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