TAG:
lab industry
Prediction of ICD-10 as Negative for Labs Comes True
IMPLEMENTATION OF ICD-10 DIAGNOSIS CODES in the United States happened on Oct. 1, 2015. At that time, a national laboratory association predicted that use of ICD-10 codes would cause Medicare Administrative Contractors (MACs) to pay labs less often and with lower reimbursement. The Dark Report ag…
2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends
This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…
Labs Need to Act on New Medicare Enrollment Rules
CEO SUMMARY: For all healthcare providers—including clinical laboratories and pathology groups—a new rule became effective this month. The rule allows Medicare to revoke or deny enrollment if a provider or supplier’s affiliates pose an undue risk of fraud. Lawyers familiar with the …
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
What Comes Next for the Pathology Profession?
IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Concerns Raised Over Pharmacogenetic Tests
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…
After Two-Year Battle with CMS, True Health on Verge of Collapse
CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health filed fraudulent claims and the federal Medicare program cut all payments to the lab company and one month later reduced the cut to 35% of the billed amount. Two months ago, CMS ended all payments again. These facts became …
After Two-Year Battle with CMS, True Health Diagnostics on Verge of Collapse
This is a synopsis of three in-depth articles in the Aug. 12, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: In 2017, an auditor for CMS alleged that True Health Diagnostics f…
By 2025, the Millennial Generation Will Dominate Lab, Pathology Workforce
This is an excerpt of a 2,576-word article in the July 22, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Within five years, members of the millennial generation will make up 75% of the physician workforce in…
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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