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.
Technical Assessment Challenges for Z-Code Applications
CEO SUMMARY: Effective on Aug. 1, UnitedHealthcare will require Z-code submissions for many genetic tests. During a recent webinar, experts tackled a topic that may prove troublesome for labs seeking Z-codes: technical assessments. Key advice is to provide specific data about clin…
UnitedHealthcare’s Z-code Policy Starts on Aug. 1
CEO SUMMARY: UnitedHealthcare’s (UHC) response to the ever-growing number of unique genetic tests and the continuing growth in the volume of those claims is a new policy. Effective Aug. 1, UHC will require a Z-code with genetic test claims. This req…
CMS: TJC Made ‘Business Decision’ to Not Recognize COLA
Following up on a prior briefing, The Dark Report has learned that the Centers for Medicare and Medicaid Services (CMS) does not appear to hav…
UHC’s Z-Code Requirement to Commence on Aug. 1
CEO SUMMARY: In what may be an alarming development for certain clinical laboratories, as of Aug. 1, UnitedHealthcare will require Z-codes for molecular test claims filed under its co…
Kaiser Acquires Geisinger Health in Value-Based Deal
CEO SUMMARY: This blockbuster combination of two respected integrated delivery networks (IDNs) caught the hospital industry by surprise. Post-closing, Kaiser and Geisinger will have combined revenue…
Kaiser-Geisinger Acquisition Sets Stage for More Deals
CEO SUMMARY: Even as experts were predicting more consolidation among multi-hospital health systems at the Executive War College in New Orleans last month, acquisition of Geisinger Health by Kaiser …
Major Events on Horizon to Reshape Lab Market
CEO SUMMARY: Speakers at last month’s Executive War College discussed a range of significant trends and changes happening today in the U.S. healthcare system. Two of the most important trends are …
Quest, Labcorp Both Report Growth in Base Lab Business
DURING THE LATEST QUARTERLY EARNINGS REPORTS from Quest Diagnostics and Labcorp, it was largely “same old, same old” as base business continues to improve post-pandemic, while C…
Draft Rule Standardizes Electronic Signatures
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
Quest Acquires Lab Outreach from New York-Presbyterian
IT’S THE LATEST DEAL THAT AFFIRMS STATEMENTS by executives of the two largest national labs that hospital CEOs have a growing interest in selling their laboratory outreach businesses. Recently, Quest Diagnostics announced that it will take over the labor…
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.