TAG:
diagnostic lab
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Medicare Demands Force PGx Lab into Bankruptcy
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx …
January 30, 2017 Intelligence: Late Breaking Lab News
In New Jersey, a U.S. attorney has put laboratory sales reps on notice that they can be prosecuted for violating federal anti-kickback laws and sent to prison. On January 18, Paul Fishman, U.S. Attorney for New Jersey, announced the sentencing of Michael J. Zarrelli, of Berkeley Heights, N.J., forme…
Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand
CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the…
NJ Lab Sues to Challenge Payers About Its Out-of-Network Status
ONE WAY THAT A CLINICAL LAB can fight back against insurers who refuse to pay lab test claims is to sue them. That’s exactly what Medical Diagnostic Laboratories of Hamilton, N.J. is doing! Not only has MDL filed lawsuits against two major health insurance companies, but in one la…
January 9, 2017 Intelligence: Late Breaking Lab News
December 27 was the 100th birthday of pathologist Jan Steiner, MD, FRCP (C), FCAP, remembered by many long-serving lab executives and clinical pathologists as one of the co-founders, along with James Root, PhD, of Chi Laboratory Systems in the late 1980s. This was a time when he was…
Pharmacogenomic Testing Draws $26 Million Recoupment from Medicare Audit
This is an excerpt from a 1,340-word article in the January 9 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: Phar…
Is Pharmacogenomics Testing Unaffordable for Payers?
ACROSS THE UNITED STATES, labs that perform pharmacogenomic tests complain that both government and private payers are reluctant to issue coverage guidelines and adequate reimbursement for these assays. Yet, this new class of diagnostic lab tests is the foundation of personalized and precision medici…
$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab
CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These devel…
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
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.
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