Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
This issue examines the top 10 stories from 2023, which show no immediate threats to the clinical laboratory industry, but which were mostly about developments where the consequences will influence laboratory operations in coming years. In other news, a convicted fraudster earns an eight-year prison sentence for violating EKRA.
In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.
In this issue, Clinisys CEO Michael Simpson explains new developments in digital technologies that will expand the value and role of lab test data. Also, recent cases of healthcare fraud are examined, and whole genome sequencing for newborns is shown to be gaining favor with physicians and payers alike.
This issue explores the financial difficulties of many hospitals and retail pharmacy chains, and also the problems that clinical laboratories have with proficiency testing. In addition, the Clinisys CEO discusses strategic changes that labs need to make.
In the Oct. 2, 2023, issue of The Dark Report, we look at the Food and Drug Administration’s reasoning behind a proposed rule to more strictly regulate laboratory-developed tests. Other stories outline how the SALSA bill aims to combat PAMA cuts and what steps a clinical lab took to bring outreach services back in house.
Recent court rulings involving the No Surprises Act are putting the government on the defensive about provisions of the law. Also, the continued consolidation of the IVD and national laboratory company markets has brought more influence to those lab companies. In addition, learn how clinical labs can earn money from their diagnostic data by helping private insurers navigate Medicare Advantage’s risk adjustment model.
An industry expert outlines steps pathologists can take to protect their incomes from outside pressures. Also, self-insured companies and unions are suing payers over price transparency. In addition, guerrilla Kaizen events are described in detail to control lab waste and inefficiencies.
This issue reports that one particular CPT billing code, once dubbed “fraudomatic” by an expert, is responsible for almost $1 billion in “improper” payments. Also, the architect of a one-year digital pathology rollout explains the steps his organization took in achieving this accomplishment.
This issue of The Dark Report continues our coverage of new Z-code mandates for genetic tests, including an in-depth look at technical assessments that may be required. Also, Dartmouth Health explains innovative ways it developed to recruit and retain CLSs, and potential LDT regulation is again gaining steam.
This issue examines the growing need for labs to present data to justify a genetic test earlier in processing of the claim. It also appears that more insurers will start requiring Z-codes for reimbursement of such tests, as UnitedHealthcare now does. In other news, a large laboratory system offers lessons learned on its rollout of the Epic Beaker LIS.
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Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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