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Florida Doctors Refuse to Use UHC’s Lab Ordering System
By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue
CEO SUMMARY: It may not yet be open rebellion, but UnitedHealthcare faces strong opposition in Florida from physicians- and their medical societies-over the requirement that they obtain pre-notification and pre-authorization when ordering tests listed in UHC’s laboratory benefit …
Market Price Report Rules Must Address All Issues
By Joseph Burns | From the Volume XXII No. 3 – February 17, 2015 Issue
CEO SUMMARY: Under the Protecting Access to Medicare Act, CMS must collect market price and volume data from certain labs beginning January 1, 2016. CMS will use this data to establish Part B clinical laboratory fees beginning in 2017. One lab association representing community a…
Healthcare Cost Solutions Will Continue to Pinch Lab Industry Revenues in 2015
By Mary Van Doren | From the Volume XXII No. 1 – January 5, 2015 Issue
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? With healthcare cost solutions continuing to squeeze laboratory profits, two federal agencies are pushing forw…
Lab Industry to Confront Major Issues during 2015
By Robert Michel | From the Volume XXII No. 1 – January 5, 2015 Issue
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? Not only are two federal agencies pushing forward with initiatives that will touch nearly every medical lab in the United States in the next 12 months, but other equally powerful trends c…
In Florida, UnitedHealth Delays BeaconLBS Claims Decisions
By Robert Michel | From the Volume XXII No. 1 – January 5, 2015 Issue
LAST WEEK, ONE PART OF THE Beacon Laboratory Benefit Solutions pilot program in Florida was postponed. A UnitedHealthcare spokesperson provided additional information about this decision. “We have lifted the January 1 claims impact de…
Top 10 2014 Biggest News Stories
By Robert Michel | From the Volume XXI No. 17 – December 15, 2014 Issue
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Medicare Special Stain LCD May Hinder Pathology Workflow
By Joseph Burns | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: Under a proposed rule for Medicare region J-11, a pathologist will no longer be able to use “reflex templates or pre-orders for special stains and/or IHC stains prior to review of the routine H&E.” While the proposed LCD is designed to target a relatively small number…
Level Two of Value Pyramid Defines Internal Benchmarks
By Robert Michel | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: In this second installment of our series on the laboratory value pyramid, we introduce “Level Two: Establish and Meet Standards of Value.” This second level continues the lab’s focus on its internal operations and activities. The goal is for the lab to develop the working cultu…
Public Comment Started on FDA LDT Regulations
By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
Florida Ob-Gyns Call for UHC to End BeaconLBS
By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: In Florida, obstetricians and gynecologists are complaining about the burdensome nature of the new lab test management system introduced by UnitedHealthcare. In addition to calling for an end to the program, some ob-gyns plan not to use the system, a process that could lead U…
CURRENT ISSUE

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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