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.
Kaiser-Geisinger Acquisition Sets Stage for More Deals
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Even as experts were predicting more consolidation among multi-hospital health systems at the Executive War College in New Orleans last month, acquisition of Geisinger Health by Kaiser …
Major Events on Horizon to Reshape Lab Market
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Speakers at last month’s Executive War College discussed a range of significant trends and changes happening today in the U.S. healthcare system. Two of the most important trends are …
Quest, Labcorp Both Report Growth in Base Lab Business
By Scott Wallask | From the Volume XXX, No. 7 – May 8, 2023 Issue
DURING THE LATEST QUARTERLY EARNINGS REPORTS from Quest Diagnostics and Labcorp, it was largely “same old, same old” as base business continues to improve post-pandemic, while C…
Draft Rule Standardizes Electronic Signatures
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
Quest Acquires Lab Outreach from New York-Presbyterian
By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue
IT’S THE LATEST DEAL THAT AFFIRMS STATEMENTS by executives of the two largest national labs that hospital CEOs have a growing interest in selling their laboratory outreach businesses. Recently, Quest Diagnostics announced that it will take over the labor…
IVD Firms Prepare for OTC, Home Test Market Expansion
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
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
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
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
By Robert Michel | From the Volume XXX No. 4 – March 6, 2023 Issue
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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