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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.

Will Lawsuits Re-shape Current Lab Practices?

CEO SUMMARY: Recent events in California, triggered by a lab whistleblower lawsuit filed in 2005 and unsealed in 2009, provide the latest example of how these lawsuits and related government enforcement actions can cause fundamental changes in the pricing and marketing p…

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Teamsters, UCFW Sue NID, Quest In Racketeering Case

CEO SUMMARY: For the second time in recent years, Quest Diagnostics Incorporated and Nichols Institute Diagnostics (NID) face a lawsuit alleging problems with a number of diagnostic test kits that were manufactured and sold by NID going back to 2000. The plaintiffs are two unions…

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DMetrix, Bio-Reference Labs, US Clinical Labs, Vidalia Laboratory Services

DMETRIX PREPARES TO INTRODUCE CHEAPER PATHOLOGY SCANNER PATHOLOGISTS MAY SOON BE ABLE TO PURCHASE a smaller and less expensive digital scanning system that fits on a microscope. DMetrix, Inc., of Tucson, Arizona, is working to downsize its flagship digital p…

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Will Medi-Cal Price Case Bring More Enforcement?

CEO SUMMARY: It was on May 19 that the California Attorney General and Quest Diagnostics Incorporated signed an agreement to settle allegations that Quest Diagnostics overcharged Medi-Cal, the state’s Medicaid program. It is expected that the California Attorney General will no…

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Quest Diagnostics Settles Medi-Cal Qui Tam Case

CEO SUMMARY: On May 19, the California Attorney General announced a $241 million agreement with Quest Diagnostics Incorporated that represents the largest settlement in the history of California’s False Claims Act. At issue in this whistle- blower lawsuit were allegations that Qu…

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Labs Learn About ACOs And Medical Homes

IN JUST SEVEN MONTHS, the age of accountable care organizations (ACO) begins. On January 1, 2012, the Centers for Medicare and Medicaid Services (CMS) will commence contracting with ACOs. ACOs are one of the major reforms spelled out in the 2,700-page health reform law that President Obama si…

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Office-Based Physicians Want In-Clinic Laboratories

CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…

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Seeking Market Clout, Labs Form Networks

CEO SUMMARY: Meet “Test Exchange Networks!” These are shared laboratory testing networks that have spontaneously appeared in different communities across the nation. Typically two or more local laboratories come together and begin to collaborate by sharing any number of resources. The…

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Beckman Coulter and Genoptix Offer Themselves Up for Sale

FOR DIFFERENT REASONS, last month two large companies in the lab industry put themselves up for sale. Assuming that both companies are sold, one consequence may be further consolidation in both the in vitro diagnostics (IVD) manufacturing sector and the lab testing sector. It was on Decembe…

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Our Top Ten Lab Stories Highlight Major Changes

CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …

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