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IVD Companies Launch New Assays, Analyzers, Automation
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
August 21, 2023, Intelligence: Late-Breaking Lab News
New research about ownership of physician practices will be of interest to anatomic pathologists who operate their own businesses. According to an analysis by the American Medical Association (AMA),…
CMS: TJC Made ‘Business Decision’ to Not Recognize COLA
Following up on a prior briefing, The Dark Report has learned that the Centers for Medicare and Medicaid Services (CMS) does not appear to hav…
Proposed Electronic Signature Rule Has Compliance Risks
CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …
Draft Rule Standardizes Electronic Signatures
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
Pharmacogenetic Tests Deliver for Avera Health Lab
CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…
IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
Building Collaborations to Deliver More Value
Innovative clinical laboratory leaders closely monitoring the financial health of their labs or hospitals will find plenty to chew on in this issue of The Dark Report. The laboratory team at Atrium Health in Charlotte, N…
Joint Commission Will Not Accept COLA Accreditation
CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …
CURRENT ISSUE
Volume XXX, No. 13 – September 11, 2023
Recent court rulings involving the No Surprises Act are putting the government on the defensive about provisions of the law. Also, the continued consolidation of the IVD and national laboratory company markets has brought more influence to those lab companies. In addition, learn how clinical labs can earn money from their diagnostic data by helping private insurers navigate Medicare Advantage’s risk adjustment model.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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