TAG:
diagnostic lab
New Federal Law Changes How CMS Sets Lab Prices
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…
Whole Genome Sequencing Is Poised for Clinical Use
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …
Claritas Is Example of New Lab Business Model
CEO SUMMARY: One by one, new business models for clinical laboratory testing are popping up. Each is a response to healthcare’s rapid evolution, the ongoing decline in lab test reimbursement, and the growing role for molecular diagnostics and genetic testing. In Cambridge, Massachusetts…
ACLA, CAP Comment on Final 2014 Medicare Rules
CEO SUMMARY: On November 27, as the nation prepared for the Thanksgiving holiday, the federal Centers for Medicare & Medicaid Services (CMS) announced the long-awaited final rules for 2014. Early analysis of the 1,300 pages of rules CMS released indicates that the agency moderated one…
Theranos Won’t Discuss Disruptive Lab Technology
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
Alberta Lab RFP, FTC, LabMD Biodiagnostic Lab Services Guilty Pleas
ALBERTA PROVINCE MAY SOON BID $3 BILLION CLINICAL LAB CONTRACT NEWS LEAKED ON SEPTEMBER 19 that Alberta Health Services (AHS) is preparing to issue a request for proposal (RFP) to select a company to build a state-of-the clinical laboratory facility to serve…
Attorneys for CAP Say CMS Fee Proposals Illegal
CEO SUMMARY: In its comments about a proposal to change the way CMS pays for clinical laboratory and pathology services, the College of American Pathologists (CAP) said that CMS is using faulty assumptions. CAP further commented that the CMS proposal to cap physician fee schedule payments…
Reporters & Investigators Target Fraud in Pain Management Market
PAIN MANAGEMENT IS COMING under increased scrutiny by law enforcement officials and government regulators. Even the national media have begun to notice the fraud and abuse that is rampant in this rapidly-expanding sector of healthcare. Many pathologists and clinical laboratory managers will welcome …
Feds Nail Doctors for Accepting Bribes from Labs
HALLELUJAH! FOUR DOCTORS IN NEW JERSEY HAVE PLEADED GUILTY to federal criminal charges of accepting bribes from Biodiagnostic Laboratory Services (BLS), the clinical lab company in Parsippany, New Jersey. Can any of you remember the last time that a federal prosecutor pursued crimina…
Genesis Outreach Lab Acquired by LabCorp
CEO SUMMARY: Sources say that Genesis Clinical Laboratory of Berwyn, Illinois, owned by McNeal Hospital, is being sold to Laboratory Corporation of America. Neither party has publicly acknowledged completion of the sale. It is the latest example of consolidation within the clinical lab in…
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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