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.

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CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being…

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CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …

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CEO SUMMARY: After routine testing and specimen volume declined last month, so too did the associated revenue. In response, clinical laboratories and anatomic pathology groups want to bolster their finances quickly or risk incurring more financial damage to already-fragile…

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COVID-19 Patient? Northwell Has Mobile Phlebotomy App

>CEO SUMMARY: What better way to limit the spread of a deadly novel coronavirus than to allow patients who suspect they have the COVID-19 illness to use a mobile phone to book an appointment with a phlebotomist who makes house calls? Northwell Laboratories started this service in Novem…

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Judge Rules in Theranos Case, Elizabeth Holmes Again Is News

Attorneys for former Theranos CEO Elizabeth Holmes and former President Ramesh Balwani are in court maneuvering before the federal case starts the trial phase this summer. Last week, Judge Edward J. Davila ruled that prosecutors from the federal Department of Justice …

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