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American Clinical Laboratory Association
Congressional Subcommittee Hears Testimony on FDA LDT Rule
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…
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…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
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…
CMS Ends Remote Reading of Pathology Glass Slides
By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue
CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…
Best Practices for Labs to Secure MT Program Funds
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
CEO SUMMARY: In securing federal funds for a new MT training center, ARUP Labs and the University of Utah took steps that clinical labs can follow for their own project financing. Among the key lessons is the need to showcase the work a lab does within a community to politicians and…
March 6, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue
Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…
Congress Averts PAMA Cuts to Lab Test Rates for 2023
By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue
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….
CURRENT ISSUE
Volume XXXI, No. 6 – April 29, 2024
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
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