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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.

Labs Should Prepare for Arrival of ‘Perfect Storm’

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

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British Columbia Ready for HPV Self-Collection

CEO SUMMARY: Unacceptable delays of as long as six or seven months in reporting Pap smear test results is triggering a major change in how provincial health authorities screen for cervical cancer. For example, health officials in British Columbia announced that, going forward, cervical ca…

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Lab News Briefs

Siemens to Explore Sale of Its IVD Diagnostics Unit Siemens Healthineers, Erlangen, Germany, is reportedly looking into options for sale of its in vitro diagnostics (IVD) segment. The company’s “review co…

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Artificial Intelligence: Now a Priority for Labs

CEO SUMMARY: It’s time to recognize the field of artificial Intelligence as the next major source of disruption. Not only will clinical laboratories, anatomic pathology groups, and diagnostics companies be disrupted by AI-powered technologies, but experts predict that almost eve…

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Machine Learning Poised to Give Clinical Labs New Capabilities

“One of the first questions I ask the laboratory team is ‘do you want to continue to be a factory or do you want to be a change agent in healthcare?’ They all answer that they want contribute to positive change.” —Michael Simpson …

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Labcorp and Quest Discuss Outreach Acquisition Potential

GIVEN THE POTENTIAL UPSIDE OF HUNDREDS OF MILLIONS OF DOLLARS IN ADDED REVENUES, both Labcorp and Quest Diagnostics remain on the prowl to acquire more hospital laboratory outreach …

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IVD and Lab Consolidation Reduces Choices for Labs

CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…

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Lab Data Crucial to Insurer Risk Adjustment Models

CEO SUMMARY: Payers who use risk adjustment models as part of Medicare Advantage need diagnostic data that helps them document ICD-10 diagnoses that earn them higher premium payments for sicker pat…

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Big Employers Sue Payers over Price Transparency

CEO SUMMARY: Feeling they’ve been denied access by insurance companies to price data about medical claim payments, self-funded employer plans and unions are taking their health insurance companies…

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Lab News Briefs: Labcorp, Tufts, Informa, HIMSS, Sanford, Fairview

Labcorp Buys Tufts’ Lab Outreach IN OUR LAST ISSUE, WE REPORTED THAT LABCORP HAD ACQUIRED the lab outreach services of two health systems in…

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