TAG:
genetic tests
NorDx CEO Shares Five Rules Critical to every Lab’s Success
CEO SUMMARY: To meet the financial challenges of healthcare today, clinical labs and pathology groups can follow the five classic lab rules of success. However, as noted by Stan Schofield, CEO of NorDx Laboratories in Scarborough, Maine, the “old school” methods need …
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
August 11, 2014 “Intelligence: Late Breaking Lab News”
There is a new case of crime involving a private pathology group practice. In Stockton, California, the Stockton Record reported on August 9 that pathologist Elvira Milano, M.D., was expected to post bond and be released from jail on that date. She faces charges of embezzlement while serving…
At Mid-Year, Labs Struggle to Get Paid for Many Tests
CEO SUMMARY: At a recent coding and billing conference, pathology and lab clients of one of the nation’s largest revenue management companies agreed that three trends have caused lower revenues since the start of 2014. One trend seen by labs involves higher deductibles and copayments fr…
Pathology Consolidation Underway in Washington
CEO SUMMARY: Two regional pathology super-practices have emerged in Washington State. In each case, acquisitions and mergers are fueling the growth of the two large pathology groups. In Western Washington and the Seattle metro, CellNetix is the dominant pathology group, with 53 physicians…
April 28, 2014 Intelligence: Late Breaking Lab News”
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical L…
Better Data Needed to Support Pathologists as Consultants
MULTIPLE TRENDS ARE UNFOLDING that mutually reinforce the need for pathologists and PhDs to be experts and consultants in how physicians order and follow up on molecular diagnostics assays and genetic tests. “Healthcare in the United States is approaching a tipping point that can greatly favor pat…
Labs, Path Groups Face Major Financial Issues
CEO SUMMARY: Are clinical labs and pathology groups ready for the end of fee-for-service reimbursement? That’s just one important question that will be answered at the upcoming Executive War College on Lab and Pathology Management that will take place in New Orleans on April 29-30. The …
Genetic Testing Creates New Legal Risks for Labs
CEO SUMMARY: Last month, in Seattle, Washington, a jury ordered Laboratory Corporation of America and Valley Medical Center each to pay $25 million following a lawsuit about a ‘wrongful’ birth. At issue was how genetic tests were ordered, performed, and reported. This court case is th…
Tricare, DOD Not Paying for MoPath Codes, LDTs
CEO SUMMARY: It turns out that labs serving Tricare patients are going unpaid for certain LDTs, molecular, and genetic tests. The issue of nonpayment began in January 2013 when Tricare stopped paying for these tests that were billed under the new molecular CPT codes that replaced the prev…
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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