TAG:
ivd/lab informatics
What if Congress Chooses to Pass an LDT-Specific Law?
CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…
Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule
BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…
Payer Contracts with Labs: Getting the Contract Is Just the Start
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FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Is Mobile Phlebotomy a Timely Service to Offer Health Plans?
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HHS Publishes Final Rule for Health IT Interoperability
THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Offi…
FDA & CMS Issue Letter, Agree on LDT Oversight
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
OIG Reports Its Findings about CDC’s First COVID Test Problems
ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …
Why Payers Bristle as Labs Submit Inpatient Fees for Outreach Tests
EDITOR’S NOTE: Our column, Virchow, is written…
Most IVD Firms Increase Q3 2023 Base Business Revenue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
CURRENT ISSUE
Volume XXXII, No. 1 – January 6, 2025
The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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