TAG:
laboratory association
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Is CMS Manipulating Data to Increase Medicare Fee Schedule Cuts?
This is an excerpt from a 2,150-word article in the April 3, 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: E…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Labs Ask: Does PAMA Statute Prevent Legal Challenges?
SINCE MEDICARE OFFICIALS PUBLISHED the final rule for lab test market price reporting of private payer prices last year, clinical lab industry consultants and lawyers have raised serious criticisms of the rule. The critics recognized that CMS officials wrote a final rule for the Protecting Access to…
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 …
PAMA Reporting Penalties Can Be Substantial for Laboratories
STARTING JAN. 1, 2017, there are substantial penalties for labs that fail to properly meet the complex lab test price marketing reporting requirements of the Protecting Access to Medicare Act of 2014. Labs that fail to do so face the potential of stiff, multi-million dollar fines. “Under PAMA, cli…
California’s Lab Price Data Collection Project Cuts Lab Test Prices by 10.5%
COLLECTING LAB TEST PRICE DATA is not limited to PAMA and the federal Centers for Medicare & Medicaid Services. California’s Medi-Cal program is in its second year of requiring clinical labs to submit private payer lab test price data. However, in both the fir…
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…
Labs Discover Much Complexity In Their Lab Test Price Data
DON’T EXPECT IT TO BE EASY AND STRAIGHTFORWARD when reporting the prices of chemistry panels as the final rule for lab test market price reporting rule requires. Instead, labs should expect the process to be complex and troublesome. Also, labs should be concerned that Medicare officials have threa…
Labs Have Heavy Burden to Report Lab Price Data
CEO SUMMARY: Clinical labs must assess their responsibilities to report lab test market prices to CMS as part of the Protecting Access to Medicare Act. A panel of three experts took up this topic at a recent webinar hosted by THE DARK REPORT. On June 23, the federal Centers for Medicaid &…
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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