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May 2, 2016 Intelligence: Late Breaking Lab News
Like the Sword of Damocles of Greek myth, market price reporting by labs under the Protecting Access to Medicare Act (PAMA) continues to hang over the heads of the nation’s clinical laboratories. However, instead of a threat, PAMA market price reporting may soon become a reality. News reports indi…
At Executive War College 2016, Two Big Lab Market Trends
CEO SUMMARY: What happens when 100 lab experts interact with an audience of more than 850 lab administrators, pathologists, and IVD executives from across the United States and seven other nations? A consensus of sorts emerges and during this 2016 edition of the Executive War College on L…
How to Cover Genetic Tests Confounds Health Insurers
CEO SUMMARY: Managed care experts say health insurers are being overwhelmed by the number of new genetic tests and that many labs find it tough to get paid for these tests. UnitedHealthcare just announced it will require pre-authorization of molecular and genetic tests during 2016. Me…
Payers Using Two Approaches To Price Molecular, Genetic Tests
PRIVATE PAYERS AND MEDICARE contractors are taking divergent approaches to establishing coverage policies and setting prices for molecular and genetic tests. That’s what Kuo Bianchini Tong, MS, CEO of Quorum Consulting Inc., sees happening. “One approach seeks to recognize the c…
Henry Ford Health System Laboratory Division Combines Lean with ISO 15189
CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…
Healthcare’s Ongoing Struggle: Patients or Profits?
ALL THE MISPLACED INCENTIVES OF A HEALTHCARE SYSTEM that uses fee-for-service to reimburse providers continue. The diverse spread of lab industry business intelligence presented in this issue of THE DARK REPORT vividly demonstrates that there continues to be a “best” and a “worst” in provider…
FDA Official Makes Case In Favor of LDT Guidance
CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of L…
Official Makes Case in Favor of FDA LDT Guidance
IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …
PAML Joint Venture News from The Dark Report Intelligence
November 2, 2007 PAML and HCA Agree to Start New Lab Joint Venture in Utah …
December 7, 2015 Intelligence: Late Breaking Lab News
Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…
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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