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.

Joint Commission Will Not Accept COLA Accreditation

CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …

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What’s Behind Joint Commission Move to Not Accept COLA Labs?

DURING THE NEXT TWO YEARS, a substantial number of hospitals and healthcare facilities will need to respond to The Joint Commission’s (TJC) decision to no longer recognize CLIA accreditations issued by COLA in “TJC-accredited facilities.” In the 30-year history of the current C…

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National Lab Says It Will Help with Supply Chain Services

RECOGNIZING THAT SUPPLY CHAIN ISSUES are troublesome to some of its clinical laboratory customers, one national lab company has announced it would like to help solve those issues.  In September, Quest Diagnostics issued a press release describing …

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CLIA on Path to Recognize Lab Data As a Specimen

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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Eight Macro Trends for Clinical Labs in 2023

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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How Consumers Shape Modern Laboratory Outreach

CEO SUMMARY: Each of the different generations engaging with clinical laboratory outreach programs brings their own set of expectations to a blood draw. Innovative hospital lab outreach programs should serve these differences by offering multiple options to provide appointment conve…

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2022’s Top 10 Lab Stories Confirm Challenging Times

CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …

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Babson Diagnostics’ Hybrid Model Combines Quality, Convenience

CEO SUMMARY: Responding to its own data about consumer preferences, healthcare technology company Babson Diagnostics is pursuing a new hybrid model for blood draws that it believes brings together the best of clinical laboratories and retail pharmacies. Laboratory managers and patho…

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…

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Reports Say Qiagen and Bio-Rad Discussing Potential IVD Merger

More consolidation in the in vitro diagnostics (IVD) mar­ket may soon happen. Bio-Rad Laboratories and Qiagen are reportedly in merger discussions. The Wall Street Journal, which broke the story on Oct. 10, tabbed the potential deal as being worth …

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