TAG:
lab tests
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
New Business Models for Pathology, Clinical Labs
EXPERTS OFTEN PROCLAIM THAT THE U.S. HEALTHCARE SYSTEM is slow to change and slow to adopt the management approaches, operational innovations, and new technologies that other industries use. One example is adoption of the quality management techniques that W. Edwards Deming and the Japanese develope…
CEO Describes Characteristics Of the Clinical Lab 2.0 Model
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Proj…
Diagnostic Error Rate Of 21% Revealed By Mayo Clinic Study
CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additi…
Will Medicare Lab Test Fee Cuts Happen in 2018?
CLINICAL LABORATORIES THROUGHOUT THE UNITED STATES ARE BRACING for what Medicare officials say will be fee cuts of $400 million in 2018 alone, followed by additional cuts that will total $5.4 billion over 10 years. Of great concern to community laboratories, small and rural hospitals, and physician …
Texas Lawmakers Asked to Stop UHC and BeaconLBS
CEO SUMMARY: In a letter to the Texas Legislature, 20 Texas medical societies say UnitedHealthcare’s BeaconLBS program would be detrimental to patient care. The Texas Medical Association and the Texas Society of Pathologists said they were concerned that the program increases the admini…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests
CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…
LabCorp, Quest, Sonic Do Hospital Lab Deals
CEO SUMMARY: Is the New Year’s spate of deals involving the sales of hospital lab outreach programs and a new joint venture the first tremors of an impending earthquake of similar transactions? In the first 10 weeks of 2017, Laboratory Corporation of America, Quest Diagnostics, and Soni…
PAMA Data Projections Led to Decision to Sell Lab
CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in reven…
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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