TAG:
CMS
Payer Contracts with Labs: Getting the Contract Is Just the Start
By Virchow | From the Volume XXXI, No. 6 – April 29, 2024 Issue
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FDA Issues Memo to Reclassify Many High Risk IVD Assays
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
CMS Issues AI Guidance for Medicare Advantage
By Mary Van Doren | From the Volume XXXI, No. 3 – February 26, 2024 Issue
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
FDA & CMS Issue Letter, Agree on LDT Oversight
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
Published Data Show Claim Denials on the Rise, But Why?
By Virchow | From the Volume XXXI, No. 2 – February 5, 2024 Issue
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Year’s Top 10 Lab Stories Contain Surprises & Twists
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…
Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
ONCE AGAIN, THE CLINICAL LABORATORY INDUSTRY DODGED THE MEDICARE FEE-CUT BULLET. Last month, Congress passed a bill that included a one-year reprieve to the impending PAMA reimbursement cuts that were scheduled to take place on January 1, 2024. The lab industry…
Payers Are Right to Be Wary of Claims for Some LDTs’ Value
By Virchow | From the Volume XXX, Number 17 – December 4, 2023 Issue
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Proficiency Testing Ranks High as a CLIA Violation
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…
CURRENT ISSUE

Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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