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 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.
Much lies underneath the surface of UnitedHealthcare’s (UHC) new policy mandating Z-code use for molecular tests covered under its commercial health plans. This development, which creates headaches for many genetic testing companies, is analyzed in depth here. Also, one company shows how data analytics improves lab productivity and TAT.
The Dark Report examines how the acquisition of Geisinger Health by Kaiser Permanente not only sets the stage for more blockbuster hospital deals, but offers a platform for new value-based reimbursement models. Also in this issue, payers are seeking ever more documentation before they’ll pay lab test claims.
The Dark Report analyzes HHS’s draft rule that standardizes digital signatures on test orders, intended to remedy a situation in which payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible. Also included is a look at the recent OIG opinion on using gift cards to encourage patients to return home-collected samples.
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Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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