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clinical laboratory industry
Hospital Lab Data Essential For CMS Market Price Study
By Joseph Burns | From the Volume XXIV No. 10 – July 17, 2017 Issue
CEO SUMMARY: In five months, Medicare officials will implement a new Part B clinical laboratory fee schedule based on private payer lab price data submitted by certain medical laboratories required to report that data. At this year’s Executive War College, the CEO of XIFIN, Inc., reported o…
Genetic Test Pre-Authorization Goes Mainstream
By R. Lewis Dark | From the Volume XXIV No. 9 – June 26, 2017 Issue
IT IS ALWAYS A BIG DEAL WHEN ONE OF THE NATION’S LARGEST HEALTH INSURERS TAKES A MAJOR STEP. That is certainly true of Anthem’s decision to launch a new program that requires physicians to obtain pre-authorization when ordering genetic tests for its members. THE DARK REPORT is f…
Why It Matters That Your Lab Has Low Test Prices
By R. Lewis Dark | From the Volume XXIV No. 8 – June 5, 2017 Issue
TODAY, THE LAB INDUSTRY FACES A CONTRADICTION when setting prices for individual lab tests. At one extreme, a certain sector of labs seeking to win exclusive managed care contracts sets high-volume routine test prices at or below the fully-loaded cost to perform those tests. At another extreme, labor…
Federal Regulation of LDTs Subject of Proposed Bill
By Joseph Burns | From the Volume XXIV No. 6 – April 24, 2017 Issue
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
Congress Seems Ready to Tackle LDT Regulation
By R. Lewis Dark | From the Volume XXIV No. 6 – April 24, 2017 Issue
RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…
PeaceHealth Outreach Laboratory Sells to Quest Diagnostics
By R. Lewis Dark | From the Volume XXIV No. 3 – February 21, 2017 Issue
This is an excerpt from a 1,471-word article in the February 21, 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. CEO SUMMARY…
PAMA Data Projections Led to Decision to Sell Lab
By Joseph Burns | From the Volume XXIV No. 3 – February 21, 2017 Issue
CEO SUMMARY: Following passage of the Protecting Access to Medicare Act of 2014, officials at PeaceHealth and PeaceHealth Laboratories began to model the financial effect this law would have on this long-established hospital lab outreach program. Based on projections of a 20% cut in reven…
PeaceHealth Labs Sold To Quest Diagnostics
By Joseph Burns | From the Volume XXIV No. 3 – February 21, 2017 Issue
CEO SUMMARY: In Oregon, one of the nation’s more successful and long-established health system outreach laboratories will cease to exist following its sale to Quest Diagnostics Incorporated. The seller explained that the Medicare Part B price cuts coming as a result of the PAMA market p…
Lab Innovators Advocate Need for Clinical Lab 2.0
By Robert Michel | From the Volume XXIV No. 2 – January 30, 2017 Issue
CEO SUMMARY: It is generally recognized that the clinical lab industry faces a financial squeeze of unprecedented dimensions. Lab test prices are falling steadily and more major cuts are coming to Medicare Part B fees in just 11 months. At the same time, obtaining favorable coverage and r…
Theranos implosion was the first Big Story of 2016
By Mary Van Doren | From the Volume XXIII, No. 17 – December 19, 2016 Issue
This is an excerpt from a 3,200-word article in the December 19 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. …
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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