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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CAP Loses Accreditation Clients to Joint Commission
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…
Why Are Health Systems Changing CLIA Accreditors?
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: It is uncommon for a major health system to switch its CLIA lab accreditation business from one accrediting body to another. Yet, just in the past 18 months, that decision was made by the Veterans Administration, Ascension Health, and Providence Health. This is an impor…
Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
“We believe the ability to work with just two drops of blood, plus the…
2020’s Top 10 Lab Stories Are Without Precedent!
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day. …
Medicare COVID Test Coding May Become a ‘Logistical Nightmare’
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests. The federal Centers for Med…
Community Lab Ceases after 37 Years of Operation
By Robert Michel | From the Volume XXVII, No. 15 – October 26, 2020 Issue
CEO SUMMARY: In Pennsylvania, one of the state’s largest independent clinical laboratories, HNL Lab Medicine in Allentown, acquired a lab competitor last month, Northeastern Laboratory Medicine in Hazelton. The deal is a good strategic move for both labs because HNL will continue to…
High-Complexity Mobile Labs for COVID-19 Testing
By Robert Michel | From the Volume XXVII, No. 14 – October 5, 2020 Issue
CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all…
Understanding COVID-19’s Changes to Lab Industry
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…
CURRENT ISSUE

Volume XXVIII, Number 2 – February 8, 2021
VARIANT SEQUENCING FOR COVID-19 is the next big opportunity for clinical labs and pathology groups. It is currently being undertaken by large labs and academic medical centers, but local labs could be next. Also, The Dark Report reports on a highly successful collaboration on a COVID test between a university and a commercial company.
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Topics
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- Clinical Laboratory Trends
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- Laboratory Equipment
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- Laboratory Management
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- Pathology Trends
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