TAG:
clinical lab
Concerns Raised Over Pharmacogenetic Tests
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…
After Two-Year Battle with CMS, True Health on Verge of Collapse
CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health filed fraudulent claims and the federal Medicare program cut all payments to the lab company and one month later reduced the cut to 35% of the billed amount. Two months ago, CMS ended all payments again. These facts became …
ACLA Gets Procedural Win in Its Appeal of PAMA Case
IN A SIGNIFICANT WIN for the American Clinical Laboratory Association (ACLA) and other groups suing federal Department of Health and Human Services (HHS), the U.S. Court of Appeals for the District of Columbia ruled in the ACLA’s favor on July 30. Ruling on the ap…
Dermatologists Say Anthem Cuts Affect Patient Care
CEO SUMMARY: Deep cuts in what Anthem pays pathologists for the professional component for certain AP services are having a harmful effect on the long-standing relationships that dermatologists have with dermatopathologists, some physicians say. By disrupting these relationships, Anthem i…
In New Mexico, Three Collaborators Improve Patient Care, Outcomes
IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes. This important accomplishment in patie…
After Two-Year Battle with CMS, True Health Diagnostics on Verge of Collapse
This is a synopsis of three in-depth articles in the Aug. 12, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health Diagnostics f…
Bill Would Delay PAMA Reporting for One Year
CEO SUMMARY: For all laboratories that must report private payer price data under the Protecting Access to Medicare Act (PAMA), a new bill in congress would delay the next round of data reporting for one year and require the National Academy of Medicine to recommend ways to improve the da…
Four Insurers, Quest Developing Blockchain
CEO SUMMARY: Organizations developing blockchain technology say it is a tamper-proof method of sharing data across networks and among providers, health insurers, and health systems. The Synaptic Health Alliance includes four of the largest health insurers, a health network, and Quest Diag…
Labs Should Heed Lessons from Huge Data Breach
CEO SUMMARY: Following news last month about the biggest breach of personal health information in the clinical lab industry, lawyers representing some of the affected patients filed at least 12 class action lawsuits. Federal officials and attorneys general in multiple states also launched…
Aetna Ends Payment for Professional Component
CEO SUMMARY: As of Aug. 1, Aetna will stop paying out-of-network pathologists for the professional component review of certain clinical pathology tests. Until now, the health insurer has paid for the professional component when out-of-network labs billed for clinical lab tests using the m…
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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