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.
2015’s Top 10 Lab Stories Show Significant Changes
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…
State of Clinical Lab Industry Likely to Be Mixed in 2016
CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…
DAT: Should Patients Have Access to All Laboratory Tests?
CEO SUMMARY: Arizona’s new direct access testing law allows consumers and patients to have access to all laboratory tests without a physicians’ order. But one lab company decided not to offer all lab tests to consumers. Instead, executives at Sonora Quest Laboratories recognize that, …
Quest to Buy Outreach Lab from Hartford Health System
MORE LAB CONSOLIDATION is happening in Connecticut. Last week, Quest Diagnostics Incorporated announced it will purchase the outreach laboratory business of Clinical Laboratory Partners. CLP is a division of Hartford HealthCare, a health system with …
New DAT Law, Competition Heat Up Phoenix Market
CEO SUMMARY: In Arizona, Theranos supported a new state law this year that allows patients to order lab tests without a doctor’s order. Since the law took effect, that law and the ultra-low prices offered by Theranos are drawing away some cash-paying customers from one lab company that …
Tasso’s Device Collects Capillary Blood for Testing
CEO SUMMARY: In Seattle, Tasso Inc., a start-up company, is developing a device that adheres to the skin and collects capillary blood that can be used for lab testing. Tasso says the device is a less invasive than a venipuncture. At the same time, executives at Tasso recognize that, for m…
UnitedHealth Not Paying Lab Claims of Some Docs
CEO SUMMARY: It continues to be tough going in Florida for UnitedHealthcare and its contractor, BeaconLBS. Efforts to implement the UHC laboratory benefit management program face stiff resistance from some physicians and a number of state medical associations. One primary care gr…
New Company Ready to Heat Up Slow Digital Pathology Market
CEO SUMMARY: There’s a new competitor in the digital pathology marketplace with ambitious plans to deliver a fully-integrated pathologist workflow solution. Inspirata, Inc., of Tampa, Florida, made its debut in March at an international pathology conference. In this exclusive i…
How Price Transparency Increased Lab’s Revenue
CEO SUMMARY: In California, a gene testing firm is increasing satisfaction among patients and physicians with a tool that provides patients with an estimate of the anticipated cost—before the physician orders a test! By providing transparency about the cost of tests upfront, Co…
Theranos, Capital Blue Sign Lab Test Agreement
CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…
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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