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.
Newer, Smaller Analyzers Will Bring Big Data to Labs
CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…
LabCorp, Sysmex Will Collaborate To Develop Liquid Biopsy Tests
ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer. The collaboration call…
Opko Pays $1.47 Billion to Buy Bio-Reference Lab
CEO SUMMARY: It’s a case of the little fish gobbling the big fish, as Opko Health – with revenue of $91 million – will be acquiring Bio-Reference Laboratories, with revenue of $832 million. But the more interesting aspect of the story is that the CEO of Opko Health is a physi…
Some Florida Docs Are Not Using BeaconLBS System
CEO SUMMARY: Some physicians in Florida are not complying with UnitedHealthcare’s laboratory benefit management program since the claims impact took effect on April 15. Although officials from UnitedHealthcare and BeaconLBS, a business division of LabCorp, state publicly that the…
New Lab Industry Trends Require Responses by Labs
CEO SUMMARY: One stark difference between the presentations delivered at last year’s Executive War College and this year’s presentations in New Orleans last week was near-unanimous recognition that the era of fee-for-service payment is soon to end! Speaker after speaker urged the…
LabCorp Prepares to Expand Direct-to-Consumer Test Program
RECENT DEVELOPMENTS MAKE IT SEEM as if lab test orders signed by physicians might soon go out of style. Last month in Arizona, Theranos played a role in changing a state law that now lets consumers order their own clinical laboratory tests without a physician’s order. Then, before the end of …
Our Editor Describes Visit to Theranos Test Center
CEO SUMMARY: Theranos now operates wellness centers in Walgreens in Palo Alto, California, and Phoenix, Arizona. It continues to claim it is transforming the lab testing experience for patients and physicians. It says it can perform hundreds of lab tests, using a finger stick col…
COLA Questions UHC on BeaconLBS Accredit Rules
CEO SUMMARY: UnitedHealthcare’s ‘Laboratories of Choice’ network in Florida accepts only labs accredited by the College of American Pathologists and The Joint Commission. In March, COLA wrote to UnitedHealth to question this policy which excludes labs accredited by the five other…
What’s New at Theranos? Lab Firm Expands in AZ
CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering…
Will Federal Prosecutors Pursue HDL Lab Execs and Physicians?
WHERE WAS MUCH TO BE LEARNED when, on April 9, federal prosecutors announced settlements of multiple whistleblower lawsuits against Health Diagnostics Laboratory, Inc. of Richmond, Virginia, and Singulex Inc. of Alameda, California. First, the Department of Justice structured a…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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