TAG:
pathologists
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
Hospital Board Expressed Doubts about Lab Billing
CEO SUMMARY: Pass-through billing arrangements, particularly those involving clinical laboratory tests, have long been recognized by healthcare attorneys as having great potential to violate certain federal and state laws. Despite this fact, board members of a financially-struggling commu…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…
Two Major, Disruptive Changes Coming to Labs
TWO MAJOR, DISRUPTIVE CHANGES lie ahead for both clinical laboratories and anatomic pathology group practices. Each disruptive factor has nothing to do with how payers select in-network labs or reimburse for lab testing services. Rather, one of these two major changes involves fundamental advances i…
Health insurance fraud cases take new turn with HDL-BlueWave outcome
This is an excerpt from a 2,700-word article in the February 12, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY:…
Strategies to Offset Medicare Cuts to Be Shared at Exec. War College
DEEP PRICE CUTS to the Medicare Part B Clinical Laboratory Fee Schedule was the big story of 2017. The big story of 2018 may be the widespread financial disruption to the clinical lab industry as labs see dramatic declines in their revenue from these Medicare fee cuts. One early opportunity for lab …
NILA: CLIA Proposal Doesn’t Address Flaws
CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive o…
GE Healthcare Sells Omnyx to Inspirata
CEO SUMMARY: Now that the FDA has cleared a digital pathology for use in primary diagnosis, interest in DP is building. Inspirata purchased Omnyx and its assets because the Omnyx Dynamyx digital pathology software has strong features that could be integrated into Inspirata’s digital pat…
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
Use of ‘1099 Marketers’ and Lab Compliance Risk
CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements….
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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