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Centers for Medicare and Medicaid Services
CLIA on Path to Recognize Lab Data As a Specimen
CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …
PAMA Cuts Have Simply Been Kicked Down the Road
PAYMENT RATE CUTS FOR CLINICAL LABORATORY TESTS, called for under the Protecting Access to Medicare Act of 2014 (PAMA), have been avoided temporarily—again. A down-to-the-wire bill in Congress to keep the federal government funded into the new year in…
Eight Macro Trends for Clinical Labs in 2023
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Congress Averts PAMA Cuts to Lab Test Rates for 2023
CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….
How Genomic Testing Labs Can Improve Their Relationships with Payers
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Feds Target Genetic Test and Telemedicine Fraud
MEDICARE FRAUD TOTALING $562 MILLION in genetic and cardiovascular tests is at the heart of recent federal criminal cases involving telemedicine that names clinical laboratory owners, physicians, and healthcare marketers as defendants. A host of indictm…
On Appeal, ACLA Gains PAMA Victory in Court
CEO SUMMARY: Last month, a U.S. Court of Appeals issued a ruling that criticized how the Department of Health and Human Services originally implemented the Protecting Access to Medicare Act of 2014 (PAMA). This ruling was a win for the American Clinical Laboratory Association in its…
Clinical Laboratories Face 20% Increase in CLIA Fees
CHANGES HAVE BEEN PROPOSED to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that would raise fees by 20% for clinical laboratories and amend certain testing personnel qualifications. The American Hospital Association (AHA) has obj…
PAMA Cuts Might Be Reduced to Zero for 2023
CEO SUMMARY: Congress may soon vote on a new bill that permanently reduces the amount of price cuts to Medicare Part B lab test prices, as specified under the Protecting Access to Medicare Act of 2014 (PAMA). The Saving Access to Laboratory Services Act (SALSA) eliminates a 15% paym…
Optum to Offer Laboratory Benefits Management to other Health Plans
This is an excerpt of a 1,355-word article in the June 21, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: UnitedHealth Group subsidiary Optum announced a new laboratory benefits management program aimed at impr…
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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