TAG:
molecular diagnostic
Two Largest Payers Start Lab Test Pre-Authorization
By Joseph Burns | From the Volume XXIV No. 12 – August 28, 2017 Issue
CEO SUMMARY: Once Anthem and UnitedHealthcare establish their respective genetic test prior-authorization programs, a new era for genetic testing will commence. The 80 million beneficiaries served by these two payers make up half of the individuals who have private health insurance. It is…
Konica Minolta to Pay Up to $1 Billion for Ambry
By Joseph Burns | From the Volume XXIV No. 10 – July 17, 2017 Issue
CEO SUMMARY: It’s the second time in six years that a Japanese corporation paid a high price for a genetic testing company in the United States. Konica Minolta will purchase Ambry Genetics for $800 million at closing and $200 million upon hitting certain financial metrics. In 2011, Miraca H…
Ambry Genetics $800M Sale to Konica Minolta Is a Big Deal for Lab Industry
By Mary Van Doren | From the Volume XXIV No. 10 – July 17, 2017 Issue
This is an excerpt from a 2,026-word article in the July 17, 2017 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. …
Message to Labs: Improve Outcomes, Get Paid More Money!
By Joseph Burns | From the Volume XXIV No. 8 – June 5, 2017 Issue
CEO SUMMARY: By now, there is widespread recognition among pathologists and clinical lab managers that the era of fee-for-service reimbursement is giving way to new forms of payment that reward value. First-mover lab leaders are in the earliest stages of developing enhanced lab testing se…
CEO Describes Characteristics Of the Clinical Lab 2.0 Model
By Joseph Burns | From the Volume XXIV No. 7 – May 15, 2017 Issue
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Proj…
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…
Should Labs File Court Challenge To PAMA Price Report Rule?
By Robert Michel | From the Volume XXIII No. 16 – November 28, 2016 Issue
CEO SUMMARY: Just four weeks remain before CMS begins collecting private payer clinical laboratory test price data. Many lab industry executives have charged that Medicare officials are not following the language of the PAMA statute or the intent of Congress. At stake are $5.4 billion in …
July 25, 2016 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXIII No. 10 – July 25, 2016 Issue
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
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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