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.
Labs Should Prepare for Larger Patient Deductibles
CEO SUMMARY: Employers are taking active steps to control the year-over-year increases in the cost of health benefits. One strategy gaining favor is to move employees away from traditional health plans and enroll them in high-deductible health plans (HDHPs). This is a trend with huge fina…
Anticipating Washington’s Next Blows to Lab Testing
CEO SUMMARY: With the advent of 2013, almost every lab was responding to some type of price cut. Clinical labs are dealing with the sequential, multi-year cuts to the Medicare Part B Lab Test Price Schedule. Anatomic pathology labs are still adjusting to the expiration of the TC Grandfath…
ACO Numbers Increase, Now Cover 10% of Nation
CEO SUMMARY: A recent report by a consulting firm that tracks the ACO industry indicates that, as of the end of 2012, ACOs of all types involved—in some manner—between 25 and 31 million patients. Moreover, Medicare and private ACOs are located in regions where 45% of the population of…
Anticipating 2013 Trends in Clinical Lab and Pathology
CEO SUMMARY: Biggest news for 2013 will the impact of significant price cuts for both clinical lab and anatomic pathology testing services. But the bad news doesn’t stop there. Employers and private payers will be more aggressive in taking steps to reduce what they spend on lab testing….
RDX Alters Business Plan Due to Lab Market Changes
CEO SUMMARY: Executives at Regional Diagnostic Laboratories (RDX) made a splash last May when they announced the new company’s plans to acquire hospital laboratory outreach programs, backed by a capital commitment of $250 million. Now, in recognition of swift changes in the lab test mar…
NY Hospital Closed Due to Deficiencies in Lab
CEO SUMMARY: Lab executives and pathologists have long read about the deteriorating finances at many rural hospitals, along with their struggles to recruit and retain enough skilled laboratory staff. Now the closure of the laboratory at 37-bed E.J. Noble Hospital in Gouverneur, N…
More IVD Consolidation as Danaher Acquires Iris
CEO SUMMARY: Danaher Corporation continues to fuel growth by continually acquiring in vitro diagnostics (IVD) companies. Its latest purchase is Iris International, which manufactures automated urine microscopy systems. Danaher also has $5 billion available that it could spend in the next …
CDC Surveys Docs’ Use of Laboratory Test Results
CEO SUMMARY: There’s a treasure trove of information and insights about how physicians use clinical laboratory tests contained in survey data recently collected by a team from the Centers for Disease Control and Prevention. Designed to identify challenges in how physicians utilize labor…
Sonic Healthcare, Bio-Reference Report Financial Performance
IN RECENT WEEKS, two of the nation’s larger public laboratory companies issued their earnings reports. In both cases, revenue growth was strong, a distinct difference from the recent financial performance of their two largest lab public company competitors. It was on August 21, 2012, when …
Lab Site Visits in NZ Show Impact of Lab Contracting
CEO SUMMARY: In some ways, the story of the New Zealand’s health system’s 15-year strategy to reduce the cost of clinical laboratory testing is a cautionary tale for public laboratory companies in the United States. During THE DARK REPORT’S site visit to several private labs in New …
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Volume XXXII, No. 6 – April 21, 2025
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