Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

December 2023

2024: Year of Decision for FDA Regulation of LDTs

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA), it’s been a long road to gain the power to regulate laboratory-developed tests (LDTs). It was in 2014 when the FDA sent a notice to Congress of its intention to begin regulation of LDTs. In the decade since, there has been continuing debate about whether […]

To access this post, you must purchase The Dark Report.

2024: Year of Decision for FDA Regulation of LDTs Read More »

Year’s Top 10 Lab Stories Contain Surprises & Twists

Clinical Laboratory / Robert Michel

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence (AI) is the exception. AI is number one on The Dark Report’s “Top 10

To access this post, you must purchase The Dark Report.

Year’s Top 10 Lab Stories Contain Surprises & Twists Read More »

OPKO’s BioReference, Sonic Each Release Earnings Reports

Clinical Laboratory / Robert Michel

BELOW IS A SUMMARY OF RECENT FINANCIAL EARNING REPORTS for OPKO’s BioReference Laboratories and Sonic Healthcare Ltd’s lab operations in the U.S. This finishes our coverage of Q3-23 financial reporting by the larger public laboratory corporations. BIOREFERENCE LABORATORIES: ‘Consistent Patient Volume’ During Q3, Compared to Prior Year Within OPKO’s third quarter conference call, data specific

To access this post, you must purchase The Dark Report.

OPKO’s BioReference, Sonic Each Release Earnings Reports Read More »

Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal

Laboratory Billing / Robert Michel

ONCE AGAIN, THE CLINICAL LABORATORY INDUSTRY DODGED THE MEDICARE FEE-CUT BULLET. Last month, Congress passed a bill that included a one-year reprieve to the impending PAMA reimbursement cuts that were scheduled to take place on January 1, 2024. The lab industry caught a lucky break. On November 1, the US House of Representatives, followed by

To access this post, you must purchase The Dark Report.

Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal Read More »

Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

Laboratory Compliance / Robert Michel

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in restitution for his role in a scheme involving healthcare fraud,

To access this post, you must purchase The Dark Report.

Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence Read More »

Why Payers Bristle as Labs Submit Inpatient Fees for Outreach Tests

Managed Care Contracts / Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs.

To access this post, you must purchase The Dark Report.

Why Payers Bristle as Labs Submit Inpatient Fees for Outreach Tests Read More »

December 26, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Is the world ready for a diagnostic service that performs a whole genome sequence of embryos conceived by in vitro fertilization? That’s the business plan announced on Dec. 5 by San Francisco-based Orchid Health. In covering this development, Science wrote, “Find the embryo at lowest risk for a disease that runs in your family, touts

To access this post, you must purchase The Dark Report.

December 26, 2023, Intelligence: Late-Breaking Lab News Read More »

December 4, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

You may have thought that the long-running saga of the now-defunct Theranos had ended. But no, there is continuing litigation in the Grand Canyon State. A class action suit—In re Arizona Theranos, Inc., Litigation, Case No. 2:16-cv-2138—continues to move forward in the U.S. District Court for the District of Arizona. This class action suit has

To access this post, you must purchase The Dark Report.

December 4, 2023, Intelligence: Late-Breaking Lab News Read More »

Payers Are Right to Be Wary of Claims for Some LDTs’ Value

Laboratory Billing / Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. THERE’S PLENTY OF NOISE

To access this post, you must purchase The Dark Report.

Payers Are Right to Be Wary of Claims for Some LDTs’ Value Read More »

CLIA Lab Directors Must Watch Delegated Duties

Laboratory Management / Robert Michel

CEO SUMMARY: Laboratory accreditors warn that underestimating or overlooking the duties of a lab director can lead to citations during CLIA inspections. Presented here are the most-frequently cited violations of the CLIA lab director’s duties and responsibilities as documented during lab inspections conducted in 2022 by CAP, COLA, TJC, and A2LA. Editor’s note: This is

To access this post, you must purchase The Dark Report.

CLIA Lab Directors Must Watch Delegated Duties Read More »

;