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american clinical lab
December 19, 2016 Intelligence: Late Breaking Lab News
Pathologists and lab managers interested in developing diagnostic management teams within their hospitals and health systems will be interested in an upcoming conference on that topic. Organized by Michael Laposata, MD, PhD, Chairman of the Department of Pathology at the University of Texas …
Will Coming Medicare Fee Cuts Reduce Access to Laboratory Tests?
SEVERAL IMPORTANT clinical laboratory associations are concerned that the lab test price reporting under the Patient Access to Medicare Act of 2014 will have a negative effect on diagnostic innovation and on Medicare beneficiaries’ access to lab testing services. The American Clinical Laboratory A…
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
Attorney Cautions Laboratories Against Waiving Patient Fees
WHEN A CLINICAL LAB WAIVES patients’ fees in exchange for lab test referrals, competing labs face a legal dilemma. If the competing lab does not match the offer, it could lose volume to this aggressive sales technique. But if the lab does match the offer, it could run afoul of health plan requirem…
At FDA, Laboratory-Developed Tests Are in the Crosshairs
This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid m…
Understanding the Future Of Laboratory Medicine
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
Lab Stakeholders Take Action to Prevent Drastic Cuts in the Medicare Lab Fee Schedule
WITH MANY CLINICAL LABORATORY STAKEHOLDERS anticipating major revenue shortfalls due to the Protecting Access to Medicare Act lab test mar…
Letter from Congress to CMS Asks for Delay in PAMA Reporting
CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representati…
Letter to Florida Doctor Offers to Waive Lab Test Fees
CEO SUMMARY: Florida’s highly-competitive market for lab testing services is again seeing some lab companies use “Waiver of Charges to Managed Care Patients” agreements with physicians in situations where the lab is an out-of-network provider. This means the lab will do free testing…
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
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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