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.
COLA Questions UHC on BeaconLBS Accredit Rules
CEO SUMMARY: UnitedHealthcare’s ‘Laboratories of Choice’ network in Florida accepts only labs accredited by the College of American Pathologists and The Joint Commission. In March, COLA wrote to UnitedHealth to question this policy which excludes labs accredited by the five other…
Florida Doc Says Questions Go Unanswered by UHC
CEO SUMMARY: One common complaint about the efforts of UnitedHealthcare to introduce its unpopular laboratory benefit management program in Florida is that the insurer-and its agent, BeaconLBS, a division of Laboratory Corporation of America-don’t respond to physicians when they …
Locked Out of Payer Network, NH Hospital Opens Lab Company
CEO SUMMARY: Since Anthem launched its site of service program in New Hampshire in 2010, labs in the state’s hospitals have mostly been excluded from its network and have lost market share. Recently one community hospital developed an unusual strategy to win back those patients…
UnitedHealth Sets April 15 to Start Claims Impact of Lab Program
APRIL 15 IS THE DATE when UnitedHealthcare will begin denying laboratory claims in Florida that do not meet the requirements of its unpopular laboratory benefit management program. The health insurer sent out notices last month to alert physicians and laboratories that it will implement what it call…
PerkinElmer Launches Lab Venture in China
CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neona…
Florida Doctors Refuse to Use UHC’s Lab Ordering System
CEO SUMMARY: It may not yet be open rebellion, but UnitedHealthcare faces strong opposition in Florida from physicians- and their medical societies-over the requirement that they obtain pre-notification and pre-authorization when ordering tests listed in UHC’s laboratory benefit …
Rheumatologists Oppose UnitedHealth’s BeaconLBS
CEO SUMMARY: Yet another specialty society is opposing the laboratory benefit management program UnitedHealthcare introduced in Florida last fall. Rheumatologists have joined four other specialty physicians in saying UHC’s BeaconLBS system could be detrimental to patient care. In…
In Florida, UnitedHealth Delays BeaconLBS Claims Decisions
LAST WEEK, ONE PART OF THE Beacon Laboratory Benefit Solutions pilot program in Florida was postponed. A UnitedHealthcare spokesperson provided additional information about this decision. “We have lifted the January 1 claims impact de…
Florida Pathologists Critical of UnitedHealth and BeaconLBS
CEO SUMMARY: In a letter to UnitedHealthcare, the Florida Society of Pathologists says UHC’s pilot laboratory management program will have a negative effect on patient care by delaying access to care and timely diagnoses of disease. Signed by more than 120 members…
Lab Industry to Confront Major Issues during 2015
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? Not only are two federal agencies pushing forward with initiatives that will touch nearly every medical lab in the United States in the next 12 months, but other equally powerful trends c…
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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