TAG:
HHS
Final Rule on AI Transparency Can Benefit Clinical Labs
ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. T…
Change Healthcare Hit by Major Cyberattack
CEO SUMMARY: It was a classic ransomware attack against Change Healthcare, the business unit of Optum that is itself a division of UnitedHealth Group. On Feb. 21, this cyberattack shut down critical systems at Change Healthcare, such as those involved in accepting and forwarding prescript…
HHS Publishes Final Rule for Health IT Interoperability
THERE IS A NEW FEDERAL RULE intended to improve interoperability and portability of patient information. This rule could be a significant benefit for clinical laboratories and anatomic pathology groups. In December, the US Department of Health and Human Services (HHS) Offi…
FDA & CMS Issue Letter, Agree on LDT Oversight
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 spec…
Feds Bar Elizabeth Holmes from Government Health Programs
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 …
European Lab’s Data Breach Has Lessons for U.S. Clinical Labs
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 …
OIG Reports Its Findings about CDC’s First COVID Test Problems
ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …
Anatomic Pathology Referrals Topic of OIG Advisory Opinion 23-06
THANKS TO A RECENTLY-RELEASED ADVISORY OPINION issued this fall by the Office of the Inspector General (OIG) Department of Health and Human Services, there is a new compliance twist involving billing for the technical component (TC) for anatomic pathology procedures. A…
Healthcare Fraud Cases Include Decades-Long Cases of Deceit
Healthcare fraud cases continue to receive harsh penalties from the federal government as indicated in the case of a California clinical laboratory owner and her husband who attempted to defraud the government of millions of dollars. Lourdes Navarro and husband Imran Shams attempted to defraud ins…
SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts
ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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.
The Dark Report • 21806 Briarcliff Dr • Spicewood, TX 78669
Phone: 512-264-7103 • Toll Free Number: 800-560-6363
Email: customerservice@darkintelligencegroup.com
© 2022 The Dark Report. All rights reserved.