Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics
CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual comments were submitted in opposition (with …
Who’s For and Against FDA Draft LDT Rule? Read More »
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the specific roles each agency should have in the review and oversight …
FDA & CMS Issue Letter, Agree on LDT Oversight Read More »
ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is barred from participating in federal healthcare programs for a period of 90 years. Holmes …
Feds Bar Elizabeth Holmes from Government Health Programs Read More »
EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. CLAIM DENIALS BY COMMERCIAL …
Published Data Show Claim Denials on the Rise, But Why? Read More »
IN WHAT COULD BE A CAUTIONARY TALE FOR CLINICAL LABORATORIES, a cybersecurity researcher has reported the discovery of a medical laboratory database that publicly exposed COVID-19 test records containing people’s personal data, including their names, passport numbers, appointment details, and test results. The database, which was not password protected, contained approximately 1.3 million records, wrote …
European Lab’s Data Breach Has Lessons for U.S. Clinical Labs Read More »
INVITAE CORPORATION, A MEDICAL GENETICS COMPANY that had a $1.34 billion loss during the nine months ending Sept. 30, 2023, recently announced coming actions to cut costs and change operations. The San Francisco-based company sold “certain reproductive health assets including carrier screening and non-invasive prenatal screening” to Natera, an Austin, Texas-based company offering cell-free DNA …
Invitae Cuts Costs to Rebuild Oncology Testing Pipeline Read More »
In Australia last December, a clinical lab company was taken to court by the Office of the Australian Information Commissioner (OAIC), which deals with privacy issues. The government agency alleges that Australian Clinical Labs (ACL) had “serious and systemic” failures that enabled a cyberattack in 2022 to compromise the private health and financial data for …
February 5, 2024, Intelligence: Late-Breaking Lab News Read More »
CEO SUMMARY: Unacceptable delays of as long as six or seven months in reporting Pap smear test results is triggering a major change in how provincial health authorities screen for cervical cancer. For example, health officials in British Columbia announced that, going forward, cervical cancer screening will start with HPV tests, with patients collecting specimens …
British Columbia Ready for HPV Self-Collection Read More »
PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administration (FDA) may be the single topic of highest interest within the clinical laboratory and in vitro diagnostics (IVD) industries at this moment. If finalized in its draft form, the new regulation will radically transform a sector of laboratory medicine that uses …
FDA Has a Ticking Time Bomb with LDT Rule Read More »
GOOGLE CLOUD OF MOUNTAIN VIEW, CALIF., inked a new deal with Epic Systems designed to encourage healthcare providers to move electronic health record (EHR) data to the cloud. This relationship will include efforts to step up the use of artificial intelligence (AI) and data analytics. The deal was announced in November and included news that …
Google, Epic to Help Hospitals Migrate EHR Data to Cloud Read More »
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