TAG:
clinical laboratories
First EKRA Guilty Plea Involves Lab Kickback
By Joseph Burns | From the Volume XXVII No. 3 – February 17, 2020 Issue
CEO SUMMARY: Federal investigators wasted little time in using the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) to prosecute fraud involving clinical laboratories and providers. The manager of an opioid treatment center in Kentucky pleaded guilty last month to three counts…
January 27, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII No. 2 – January 27, 2020 Issue
In recent weeks, the Supreme Court declined to consider an appeal in a case which challenged a lab company’s patent on a clinical laboratory test. On Jan. 13, the justices rejected the appeal made by Athena Diagnostics, a division of Quest Diagnostics. In an earlie…
Two Collaborations: LabCorp-Thermo Fisher, Roche-Illumina
By Joseph Burns | From the Volume XXVII No. 2 – January 27, 2020 Issue
In deals related to the pursuit of companion diagnostics, two lab companies announced collaboration deals with companies that manufacture gene-sequencing equipment. The deals were announced on consecutive days earlier this month. Financial terms were not disclosed. On Jan. 13, Ro…
Vanderbilt Lab Uses Predictive Medicine to Improve Care
By Joseph Burns | From the Volume XXVII No. 2 – January 27, 2020 Issue
> CEO SUMMARY: The integrative diagnostics lab at the Vanderbilt University Medical Center aims to use sophisticated diagnostics to advance the use of precision medicine testing to improve patient care and to do so at an affordable cost. As part of these efforts, the lab staff …
33 Groups Cooperated to Get PAMA-Related LAB Act Passed
By Joseph Burns | From the Volume XXVII No. 2 – January 27, 2020 Issue
>CEO SUMMARY: At the end of 2019, the Laboratory Access for Beneficiaries (LAB) Act became law and addressed two of the three most onerous requirements in the Protecting Access to Medicare Act (PAMA) of 2014. It delays the data-reporting requirements under PAMA, an…
Any Hope for Relief from PAMA Medicare Price Cuts?
By R. Lewis Dark | From the Volume XXVII No. 2 – January 27, 2020 Issue
It is a notable and rare success for the clinical laboratory profession to convince the House and Senate to pass a law that is favorable to the interests of patients and the clinical laboratories that serve them. Yet that is what happened when Congress passed the Laboratory Access for Beneficiarie…
Is Health Price Transparency at Its Tipping Point?
By R. Lewis Dark | From the Volume XXVI No. 17 – December 16, 2019 Issue
Is it a coincidence that a number of uninsured consumers filed separate lawsuits in federal courts against Laboratory Corporation of America and Quest Diagnostics—alleging, in both cases, that they were overcharged for clinical…
Converting Paper Requisitions to Digital Cut Lab’s Costs
By Joseph Burns
CEO SUMMARY: Health Network Laboratories cut costs and shortened lab test turnaround time by converting paper requisitions to digital data. It did so by scanning paper requisitions and having a vendor do the required data entry. This helped the lab reduce errors in its patient data. Using…
How Northwell’s Lab Team Demonstrated Value Over 10 Years
By Joseph Burns
CEO SUMMARY: Among hospital administrators, the popular wisdom is that their clinical lab is a cost center. This thinking leads them to consider drastic cost-management strategies that include partnering with commercial labs to manage in-hospital lab testing and the outright sale of lab o…
Labs May Be Excluded from Revised Stark, AKS Rules
By Joseph Burns | From the Volume XXVII No. 1 – January 6, 2020 Issue
CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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