TAG:
the clinical laboratory
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…
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…
Labs Share Successes in Delivering More Value
By Robert Michel | From the Volume XXI No.16 – November 24, 2014 Issue
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
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…
Cigna Sues HDL, Alleges Unlawful Fee Scheme
By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue
CEO SUMMARY: In court papers, Cigna alleged that HDL misrepresented patients’ responsibilities by promising not to collect co-payments, co-insurance, or deductibles. Also, HDL promised not to seek reimbursement from patients for any portion of its bills that the health insurer did not c…
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…
Labs Working to Release Test Results to Patients
By Robert Michel | From the Volume XXI No. 14 – October 13, 2014 Issue
CEO SUMMARY: A new federal requirement requires labs to make test results available to patients beginning this month. What is unknown is how patients will respond to the opportunity to see their lab test results. The effective date for this new requirement was October 6. It is expected th…
Defining a Path to Clinical Laboratory Best-in-Class via Benchmarks
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
CEO SUMMARY: With the American healthcare system undergoing a major transformation, it is essential that all clinical laboratories and pathology groups recognize this transformation and effect the right strategies to meet the needs of physicians, patients, and payers. A g…
September 22, 2014 “Intelligence: Late Breaking Lab News”
By Robert Michel | From the Volume XXI No. 13 – September 22, 2014 Issue
Did you know that the world’s longest automation track in a clinical laboratory has just become operational in India? At 93.5 meters (307 feet), it is longer than a football field, according to a press release issued by Siemens Diagnostics. The automation was installed at the centr…
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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