TAG:
pharmacogenetics
Key Lab Trends Described At Executive War College
By Joseph Burns | From the Volume XXV No. 7 – May 7, 2018 Issue
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…
TOP 10 LAB STORIES OF 2017
By Robert Michel | From the Volume XXIV No. 17 – December 11, 2017 Issue
1. CMS Sticks by Decision to Deeply Cut Medicare Part B Lab Test Fees SHORT OF A MIRACLE, the clinical laboratory industry is less than three weeks from the single most financially-disruptive event of the past 30 years. On Jan. 1, the federal Centers for Medicare and Medicaid Service…
Medicare Demands Force PGx Lab into Bankruptcy
By Joseph Burns | From the Volume XXIV No. 5 – April 3, 2017 Issue
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 …
Pharmacogenomic testing a success at South Dakota health system
By Mary Van Doren | From the Volume XXIV No. 2 – January 30, 2017 Issue
This is an excerpt from a 2,700-word article in the January 30 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: One es…
Health System Lab Is Genotyping To Identify Best Drugs for Patients
By Joseph Burns | From the Volume XXIV No. 2 – January 30, 2017 Issue
CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …
Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand
By Joseph Burns | From the Volume XXIV No. 2 – January 30, 2017 Issue
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…
Pharmacogenomic Testing Draws $26 Million Recoupment from Medicare Audit
By Mary Van Doren | From the Volume XXIV No. 1 – January 9, 2017 Issue
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…
$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab
By Joseph Burns | From the Volume XXIV No. 1 – January 9, 2017 Issue
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…
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
By Joseph Burns | From the Volume XXIII No. 4 – March 21, 2016 Issue
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Medicare Ends Coverage for Some Pharmacogenomic Testing
By Mary Van Doren | From the Volume XXII NO. 9 – June 22, 2015 Issue
WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical labor…
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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