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acla
ACLA Suit Challenges HHS’ Data-Collection Efforts
By Joseph Burns | From the Volume XXV No. 1 – January 2, 2018 Issue
CEO SUMMARY: In a lawsuit filed last month, the American Clinical Laboratory Association charged that HHS failed to comply with the statutory requirements of the Protecting Access to Medicare Act of 2014 when setting the 2018 Clinical Laboratory Fee Schedule. In the lawsuit, ACLA said HHS…
Helping You Plan Your Lab’s Financial Future
By R. Lewis Dark | From the Volume XXV No. 1 – January 2, 2018 Issue
WE ARE NOW IN THE NEW YEAR and the 2018 Medicare Clinical Laboratory Fee Schedule (CLFS) is a reality. The dramatic price cuts that the federal Centers for Medicare and Medicaid Services has enacted is the single most disruptive financial event the clinical laboratory industry has fa…
ACLA hits Medicare fee schedule cuts with lawsuit
By Mary Van Doren | From the Volume XXIV No. 17 – December 11, 2017 Issue
This is an article from the Dec. 11, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers. This article plus a full analysis of 2017 developments in the PAMA process are available at all times to paid members of the Dark Int…
ACLA Sues HHS over Market Price Study, Fee Cuts
By R. Lewis Dark | From the Volume XXIV No. 17 – December 11, 2017 Issue
IT’S A LONG-AWAITED DEVELOPMENT! Today, a federal lawsuit was filed against the Department of Health and Human Services (HHS) by the American Clinical Laboratory Association (ACLA). The lab association is asking a federal judge to review specific actions taken by …
CMS Publishes Final CLFS Rates, Labs Prepare to Cut Staff or Close
By Joseph Burns | From the Volume XXIV No. 16 – November 20, 2017 Issue
MEDICARE OFFICIALS PUBLISHED the final Part B Clinical Laboratory Fee Schedule for 2018 last Friday. Some changes clinical labs will welcome. The rates remain deeply flawed, however, and will cause many labs to lay off staff and others to close, experts said Saturday. How CMS set the rates remains p…
Lab Associations Comment on CMS Actions, Lab Fees
By Robert Michel | From the Volume XXIV No. 14 – October 9, 2017 Issue
FOR THE LAB INDUSTRY, THE FEE CUTS proposed in the 2018 Clinical Laboratory Fee Schedule would be even more aggressive than what the federal Centers for Medicare and Medicaid Services had earlier predicted for Medicare Part B. In the days following the Sept. 22 publication of the pr…
Can Fee Cuts Be Delayed? Courts Are One Option
By Robert Michel | From the Volume XXIV No. 14 – October 9, 2017 Issue
CEO SUMMARY: Some lab companies may be prepared to challenge in court the methodology CMS used in setting the requirements of the Protecting Access to Medicare Act of 2014 to conduct a study of private payer market prices for lab tests and use that data to propose new prices for the Part …
Labs Report Problems with Anthem’s Pre-Approval
By Joseph Burns | From the Volume XXIV No. 12 – August 28, 2017 Issue
CEO SUMMARY: Since the July 1 launch of its prior-authorization program for genetic tests, Anthem and its subsidiary, AIM Specialty Health, have authorized few genetic tests, said a national lab. Lab directors say they have been unable to communicate with Anthem/AIM when client physicians…
LabCorp, Quest Talk about Medicare Lab Price Cuts
By Robert Michel | From the Volume XXIV No. 11 – August 7, 2017 Issue
CEO SUMMARY: In an effort to forestall CMS’ efforts to implement the PAMA final rule on market price reporting, Laboratory Corporation of America and Quest Diagnostics are meeting with members of Congress, officials in the administration, and the new leadership of CMS. During recent con…
2014’s PAMA Fix Comes Back to Haunt Big Labs
By R. Lewis Dark | From the Volume XXIV No. 11 – August 7, 2017 Issue
AS YOU READ THE INTELLIGENCE BRIEFINGS IN THIS ISSUE about lab industry efforts to convince Congress, the administration, and the new leaders of the Centers for Medicare and Medicaid Services to delay implementation of the PAMA final rule on market price reporting, keep in mind thatâ…
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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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