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.
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…
PAMA, LDTs and Theranos Top 2014 Biggest News
CEO SUMMARY: Not in recent memory has a single calendar year brought such a cascade of news stories that have the potential to affect nearly every clinical lab and pathology group in the United States. Blame it on the lack of money to fund healthcare and how it is motivating government an…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Labs Share Successes in Delivering More Value
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
LipoScience Could Find No Other Interested Buyer than LabCorp
ONE EXAMPLE OF HOW TOUGH TIMES ARE for companies offering proprietary or patent-protected tests is the acquisition of LipoScience by Laboratory Corporation of America in a deal that was disclosed last September. It was announced that LabCorp would pay $85 million, o…
Florida Ob-Gyns Call for UHC to End BeaconLBS
CEO SUMMARY: In Florida, obstetricians and gynecologists are complaining about the burdensome nature of the new lab test management system introduced by UnitedHealthcare. In addition to calling for an end to the program, some ob-gyns plan not to use the system, a process that could lead U…
UnitedHealth Answers Queries about Function of BeaconLBS
ANSWERS TO QUESTIONS SUBMITTED to UnitedHealthcare about the insurer’s laboratory benefit management program now coming into operation in Florida were provided by the company’s public communication officer. These answers are reproduced below: Q: Will BeaconLBS proces…
FL Docs Say: ‘No Thanks’ to UHC and BeaconLBS
CEO SUMMARY: Some Florida physicians are declaring their intent to leave UnitedHealthcare’s network because they find the insurer’s new BeaconLBS laboratory benefit management system to be time consuming and onerous. The defections come as the program goes through a soft launch that b…
Humana Reduces Number of Labs in its Networks
CEO SUMMARY: In Ohio, a lab director said his lab was not informed directly about its exclusion from the Humana lab network. Lab officials got the word from their client physicians. In Texas, another lab director said Humana cut 35 lab contracts, reportedly because the insurer wanted to s…
Physicians and Labs Wary of United’s Lab Test Program
CEO SUMMARY: Providers seem to have a natural distrust of health insurers, particularly when payers introduce new programs with the stated purpose of improving quality and ensuring that physicians deliver evidence-based medicine. Doctors serving members of UHC’s HMO plans in Florida are…
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.