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Office of Inspector General
Federal Court Reverses Conviction in AKS Case
CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
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) …
Private Health Insurers Are Aware of Problems with CPT Code 81408
EDITOR’S NO…
OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’
CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…
OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens
CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Attorney Advises Labs to Track Genetic Test LCDs
CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…
OIG: 25% of Medicare Inpatients ‘Harmed in Hospitals’ Pre-COVID
CEO SUMMARY: This year’s report to Congress on patient harm in hospitals—prepared by the Office of the Inspector General (OIG)—determined that one in four Medicare beneficiaries suffered harm while an inpatient in a hospital. The report garnered little attention outside the he…
2021’s Top 10 Lab Stories Highlight Important Trends
This is an excerpt of a 3,075-word article in the December 20, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…
CURRENT ISSUE
Volume XXXII, No. 9 – June 23, 2025
In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show executives underestimate staff AI use, raising concerns about a leadership gap in tech adoption. Clinical lab leaders must get more familiar with AI use cases. Also, in this issue of The Dark Report, there is discussion on how Medicaid cuts may affect clinical labs, an examination of the lab industry fallout from CLIAC termination, an analysis of AMP’s reports that provide crucial insights for Hiring Managers, and notes that regional health systems are new dominant players in M&A.
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