TAG:
lab risk & compliance
Congressional Subcommittee Hears Testimony on FDA LDT Rule
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
Final Rule on AI Transparency Can Benefit Clinical Labs
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
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
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
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…
CMS Issues AI Guidance for Medicare Advantage
By Mary Van Doren | From the Volume XXXI, No. 3 – February 26, 2024 Issue
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
European Lab’s Data Breach Has Lessons for U.S. Clinical Labs
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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 …
September Saw 153% Increase in Ransomware Attacks
By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue
CEO SUMMARY: Most ransomware attacks don’t generate news stories because the victimized organizations don’t want other threat actors to learn if they paid a ransom to regain access to their information systems. Experts point out that more cyberattacks are happening and that the attack…
Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
ONCE AGAIN, THE CLINICAL LABORATORY INDUSTRY DODGED THE MEDICARE FEE-CUT BULLET. Last month, Congress passed a bill that included a one-year reprieve to the impending PAMA reimbursement cuts that were scheduled to take place on January 1, 2024. The lab industry…
Anatomic Pathology Referrals Topic of OIG Advisory Opinion 23-06
By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue
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
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
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…
Proficiency Testing Ranks High as a CLIA Violation
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
CURRENT ISSUE
Volume XXXI, No. 6 – April 29, 2024
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
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