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Clinical Laboratory Trends

Clinical laboratories, where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease, are facing numerous challenging trends as healthcare reform continues to evolve.

Some of these clinical laboratory trends include:

  • The Protecting Access to Medicare Act (PAMA) of 2014.

    Under PAMA, many clinical lab organizations will see a substantial decline over the coming years in the prices paid to them for the highest-volume lab tests reimbursed under Medicare Part B. The law specifies that the federal Centers for Medicare & Medicaid Services (CMS) can begin enacting those price cuts in 2017.

  • Laboratory benefit management program

    The laboratory benefit management program is a controversial program created by UnitedHealthcare in 2014. All outpatient laboratory services for members who are part of the Laboratory Benefit Management Program are subject to new requirements including advance notification and new medical policies.

    Physicians serving UHC’s commercial patients in Florida must notify UHC when ordering any of 80 clinical laboratory tests. Pre-authorization is also required for certain tests.

    During its introduction phase, the program has generated widespread resistance from Florida physicians, who protest that it will cause unnecessary delays for patient treatment, and undue burdens for doctors ordering tests. In addition to problems with lab test pre-notification algorithms within the BeaconLBS system, other problems cited by physicians include the exclusion of all but 13 Florida labs from the BeaconLBS “laboratory of choice network.”

  • Accountable care organizations

    ACOs are the product of a provision in the Affordable Care Act of 2010. They are integrated care networks of providers with the ability to provide care to, and manage patients, across the continuum of care that should include different institutional settings, such as ambulatory care, inpatient hospital care, and even post-acute care. Clinical labs have had difficulty gaining entry into newly- forming ACOs.

At the same time, a positive clinical laboratory trend is the increasing popularity of personalized medicine (PM), a medical model that proposes the customization of healthcare – with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is critically important, as it is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.

Abbott Says It Will Split into Two Firms in 2012

FURTHER CHANGES ARE COMING to the in vitro diagnostics (IVD) marketplace. On October 19, Abbott Laboratories, Inc., announced that it would separate into two publicly-traded companies sometime in 2012. One business will be the medical devices and diagnostics business. It w…

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At Kaiser Permanente, Real-Time Lab Results Are a Hit with Patients

CEO SUMMARY: Should patients be allowed to see their own lab test results when they are available to their physicians? Kaiser Permanente believes so. Since 2005, Kaiser Permanente has given members real-time access to most laboratory test results in their personal health record (PHR) on w…

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Are Prosecutors Afraid of Big and Little Lab Firms?

CEO SUMMARY: Settlements in the big whistleblower suits involving major lab companies typically generate national headlines. But seldom do the views of the “quiet majority” of lab owners and lab executives get much attention. These are the majority of lab professionals workin…

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Rosetta Genetics, Aureon Biosciences, Plus Diagnostics, Atherotech, Sequenom

ROSETTA GENOMICS TO LAY OFF 35 EMPLOYEES TO CUT EXPENSES AND SHIFT MORE FUNDING toward sales of its proprietary molecular tests, Rosetta Genomics says it will eliminate 35 jobs. The company, based in Israel, operates a clinical laboratory in Philadelphia, Pe…

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National Group Names Riedel “Whistleblower of the Year”

WHISTLEBLOWING HAS ITS REWARDS. During 2011, one laboratory whistleblower not only harvested tens of millions of dollars in settlement awards, but he was recently honored by a national group for these same efforts. Chris Riedel, President of Hunter Laboratories, Inc., in Campbell, C…

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Using Accurate Data to Grow Lab Outreach

CEO SUMMARY: In recent years, the laboratory outreach program at the Robert Wood Johnson University Hospital in New Brunswick, New Jersey, has achieved impressive rates of growth in specimen volume and net revenue. One reason for this success is that the lab outreach program moni…

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Thermo Fisher, Intrinsic Bioprobes, Kaiser Permanente, UCSF, CLMA, ASCLS

THERMO FISHER BUYS INTRINSIC BIOPROBES, CONTINUES BUYING SPREE IT’S ANOTHER ACQUISITION FOR Thermo Fisher Scientific, Inc., of Waltham, Massachusetts. It purchased Intrinsic Bioprobes, Inc., of Rochester, New York, earlier this month. A m…

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Sonic Healthcare Ltd., Reports Full Year Earnings for FY 2011

ON AUGUST 23, Sonic Healthcare Ltd., of Sydney, Australia, released its financial results for its fiscal year ending June 30, 2011. This provided an opportunity to assess Sonic’s impact in the United States, where it has regularly expanded its testing activities. Sonic reported st…

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Rhode Island Lab Educates Consumers about Lab Prices

TWIN TRENDS NOW CREATE an opportunity for clinical labs and pathology groups to build market share. But tapping these new buyers of laboratory tests will require labs to communicate more effectively with consumers. One trend is the growth in enrollment in health plans that require higher deductibles…

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Quest Diagnostics and LabCorp Report Second Quarter Earnings

JUST ONE DAY APART, the nation’s two largest laboratory testing companies reported second quarter and half-year earnings for 2011. Each financial report opened a window into marketplace developments for the first six months of this year. First to release its earnings report was Quest Diagn…

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