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laboratory industry
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…
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…
FL Docs Say: ‘No Thanks’ to UHC and BeaconLBS
By Joseph Burns | From the Volume XXI No. 14 – October 13, 2014 Issue
CEO SUMMARY: Some Florida physicians are declaring their intent to leave UnitedHealthcare’s network because they find the insurer’s new BeaconLBS laboratory benefit management system to be time consuming and onerous. The defections come as the program goes through a soft launch that b…
Did Labs Rip Off Medicare? Feds Are Investigating
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
CEO SUMMARY: One reason why there is not a level playing field in lab industry compliance with laws governing kickbacks and anti-business behavior is that government officials do not act quickly against the lab industry’s worst offenders—if they take any action at all. News of a feder…
PAMA’s New Rules Affect Lab Test Pricing, Coverage
By Joseph Burns | From the Volume XXI No. 8 – June 9, 2014 Issue
CEO SUMMARY: For several reasons, the “Protecting Access to Medicare Act” (PAMA) has the potential to be the most disruptive federal legislation directed at the clinical lab industry since the enactment of CLIA 1988. Following passage of the law, some lab industry groups have taken di…
Speakers in New Orleans Offer Important Insights
By Robert Michel | From the Volume XXI No. 7 – May 19, 2014 Issue
CEO SUMMARY: In coming years, there will be multiple challenges and opportunities for the nation’s clinical laboratories and pathology groups. That was one common theme heard from the 90 speakers and panelists at the 19th annual Executive War College on Laboratory and Pathology Manageme…
New Skills Needed for Difficult Lab Job Market
By Joseph Burns | From the Volume XXI NO. 6 – April 28, 2014 Issue
CEO SUMMARY: Across the nation, a small but growing number of pathologists and lab directors has begun to engage career coaches and management recruiters specifically to sharpen their interviewing and career development skills, even though they are still employed. One expert says this tre…
April 28, 2014 Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XXI NO. 6 – April 28, 2014 Issue
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
Congress’ New SGR Law Has Mixed News for Labs
By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
New Federal Law Changes How CMS Sets Lab Prices
By Robert Michel | From the Volume XXI No. 5 – April 7, 2014 Issue
CEO SUMMARY: CMS wanted more power to cut the prices it pays for clinical lab testing. A significant part of the lab industry wanted more transparency and consistency in how CMS established coverage guidelines and prices for new lab tests. Congress appears to have attempted to craft a law…
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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