TAG:
College of American Pathologists
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
Negotiating Path Contracts with Hospitals, Third Parties
PART THREE OF A SERIES TO HELP ANATOMIC PATHOLOGY GROUPS THRIVE AND PROSPER during these challenging times, The Dark Report presents this third installment in a series that identifies clinical, operational, and financial strategies pathology groups…
Pathologist Frederick Kiechle, MD, Molecular Pioneer, Dies at 78
Clinical pathology lost one of its greatest practitioners when pathologist Frederick L. Kiechle, MD, PhD, FCAP, of Cooper City, Fla., died on July 30, 2024, at the age of 78. …
October 14, 2024, Intelligence: Late-Breaking Lab News
Babson Diagnostics of Austin, Texas, received a “strategic investment” from Becton, Dickinson and Company (BD). The amount of the investment was not disclosed. In the past year, Babson launched an innovative lab testing service with retail pharmacies in Austin an…
What if Congress Chooses to Pass an LDT-Specific Law?
CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…
How Private Health Insurers May Respond to FDA LDT Regulation
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Congressional Subcommittee Hears Testimony on FDA LDT Rule
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
Examining the Worldwide Pathologist Shortage
CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in eac…
March 18, 2024, Intelligence: Late-Breaking Lab News
In California last month, Quest Diagnostics entered into a settlement agreement with California Attorney General Rob Bonta and nine local district attorneys. KCRA News of Sacramento reported that the “settlement resolves allegations that the company unlawfully disposed of …
CLIA Lab Directors Must Watch Delegated Duties
CEO SUMMARY: Laboratory accredito…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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