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.
IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
Best Practices for Labs to Secure MT Program Funds
CEO SUMMARY: In securing federal funds for a new MT training center, ARUP Labs and the University of Utah took steps that clinical labs can follow for their own project financing. Among the key lessons is the need to showcase the work a lab does within a community to politicians and…
Enzo Biochem’s Lab Business Sold to Labcorp for $146M
COMMERCIAL LABORATORY CONSOLIDATION CONTINUES, this time with news earlier this month that New York City-based Enzo Biochem agreed to sell its clinical laboratory business to Labcorp. The deal points to the problem many clinical laboratori…
Sanford Health to Merge with Fairview Health Services
CEO SUMMARY: It’s the latest example of a merger involving two big integrated delivery networks (IDNs). Sanford Health in South Dakota inked an agreement to merge with Fairview Health Services in Minneapolis. This deal confirms the growing trend of consolidation among multi-hospit…
Laboratory Implications of Sanford/Fairview Merger
CEO SUMMARY: Not too many years ago, many hospitals and health systems were bullish on their laboratory outreach businesses. But financial pressures on hospitals and health systems may be causing the pendulum to swing in the direction of hospitals selling their lab outreach programs…
ARUP Laboratories and University of Utah Create MT Training Center
CEO SUMMARY: To help resolve the ongoing shortage of MTs and MLSs, ARUP Laboratories and the University of Utah’s Medical Laboratory Sciences Division took a novel approach to secure funding for a new laboratory scientist training center. They worked with their congressional repre…
Labcorp: Ascension Deal Will Earn $550 Million in 2023
PUBLICLY TRADED LABORATORY COMPANIES OFFERED INSIGHTS into how acquisitions of hospital lab operations and outreach businesses add to their bottom lines, according to recent reports on full-year 2022 and fourth quarter earnings. Last year was a busy one…
CAP, Joint Commission Under Pressure to Add More Inspectors
CEO SUMMARY: Like the clinical laboratories they accredit to the requirements of CLIA, The Joint Commission and College of American Pathologist (CAP) face recruitment and hiring pressures when it comes to their surveyors and inspectors. Labs involved with CAP’s peer inspections ma…
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 …
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.