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.
Intermountain Health Merges with SCL Health
CEO SUMMARY: Mergers and acquisitions involving large integrated delivery networks (IDNs) are not only reshaping the nation’s hospital industry. These transactions also transform the way hospitals organize their clinical laboratories. Last month’s merger of Intermountain Health …
‘Lab Workforce Crisis Takes Top Spot’–CAP Today
CEO SUMMARY: Just weeks ago, CAP Today characterized the current crisis in staffing clinical laboratories as going “from simmer to rolling boil.” Demand for medical technologists and other certified laboratory scientists far exceeds the supply. Consequently, many labs now…
Anticipating Change in COVID-19 Test Volume
CEO SUMMARY: New and more easily transmitted variants of SARS-CoV-2 are causing surges…
New Trends Reshaping Healthcare, Lab Testing
…
Labs Use IoT Tools for Specimen Logistics
CEO SUMMARY: Internet of Things (Io…
March 14, 2022 Intelligence: Late-Breaking Lab News
Telehealth proved to be popular with Medicare patients during the SARS-CoV-2 pandemic. The federal U.S. Department of Health and Human Services (HHS) reported telehealth visits for Medicare beneficiaries increased in 2020 by an incredible 63 times—from approximately 840,000 in 2019 to 52.7 m…
Quest and Walmart to Expand Consumer-Initiated Test Options
SERVING CONSUMERS INTERESTED IN ORDERING THEIR OWN CLINICAL LABORATORY TESTS is a goal in an expanded collaboration involving Quest Diagnostics and Walmart. This is also consistent with The Dark Report’s prediction that retail pharmacies are poised to expand the diagnostic testing ser…
Newsmaker Interview
…
Microbiome Startups Pushing into the Clinical Lab Space
REPUTABLE CLINICAL LABORATORY COMPANIES HAVE A NEW COMPETITOR in what has been called the Wild West of microbiome startups. Some of the companies in this nascent industry have been hailed for developing health breakthroughs while others have been indict…
XIFIN Buys OmniSYS, Bridges Lab to Pharmacy
CEO SUMMARY: XIFIN’s acquisition of pharmacy technology company OmniSYS is the latest evidence that retail pharmacies are preparing to become a new front door to healthcare for consumers. The deal allows XIFIN to bring clinical lab information about patients directly to pharmacist…
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.