Month: November 2014

Dark Daily

November 24, 2014 Intelligence: Late Breaking Lab News

Interesting things are unfolding in San Diego with Pathway Genomics, a company with a CLIA lab that offers genetic testing to physicians. On November 12, it was announced that the IBM Watson Group had invested in Pathway Genomics. The two companies said that they are teaming up to deliver “the first-ever cognitive consumer-facing app, based …

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Attorneys Outline Issues in FDA’s LDT Guidance

CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify if LDTs are safe, accurate, or efficacious, …

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Level Two of Value Pyramid Defines Internal Benchmarks

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 culture and staff training required to identify relevant …

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Medicare Special Stain LCD May Hinder Pathology Workflow

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 of pathologists who regularly overutilize special stains, …

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California Hospitals Become Health Insurers

WHAT CHANGES WHEN THE NATION’S HOSPITALS become health insurers? How do pathology practices and clinical laboratories contract to provide lab testing services when their parent hospital is also the insurer? We are about to learn the answers to these questions by watching California. News outlets are reporting that Sutter Health, one of California’s largest integrated …

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Labs Share Successes in Delivering More Value

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 recognize that fee-for-service reimbursement is on the way out. They want to get …

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LipoScience Could Find No Other Interested Buyer than LabCorp

ONE EXAMPLE OF HOW TOUGH TIMES ARE for companies offering proprietary or patent-protected tests is the acquisition of LipoScience by Laboratory Corporation of America in a deal that was disclosed last September. It was announced that LabCorp would pay $85 million, or $5.25 per share, for LipoScience, which analysts said valued the company at just …

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Public Comment Started on FDA LDT Regulations

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 bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased …

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Florida Ob-Gyns Call for UHC to End BeaconLBS

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 UHC to deny payment to clinical labs. In a …

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Cigna Sues HDL, Alleges Unlawful Fee Scheme

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 cover, the court documents show. HDL misleadingly billed the health insurer at exorbitant …

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