American Clinical Laboratory Lawsuit Charges HHS Ignored Congress’ Intent When Collecting Market-Rate Data for 2018 Clinical Laboratory Fee Schedule

In filing Monday, lawsuit seeks to force HHS to comply with PAMA’s statutory requirements and to withhold applying the new Clinical Laboratory Fee Schedule until HHS has revised the final rule appropriately Many clinical laboratory executives will welcome the news that a lab industry trade association has filed a lawsuit in federal court in an effort to delay and fix the final rule for Protecting Access to Medicare Act of 2014 (PAMA) private payer lab test market price reporting that Medicare...

American Clinical Laboratory Association’s Annual Meeting Takes Place in Washington, DC, as Congress Considers First Obamacare Repeal-and-Replace Bill

CMS Director speaks at ACLA meeting; acknowledges that labs are alerting the agency to problems with Protecting Access to Medicare Act (PAMA) private payer market reporting, but did not say whether a delay in implementing either reporting or lab test fee cuts would be possible WASHINGTON, DC—Last week, it was symbolic that, as members of the American Clinical Laboratory Association (ACLA) assembled for their annual meeting, members of the House of Representatives were preparing to vote on the...

Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance. One example involves researchers at the Northwestern University Feinberg School of...

Congress Passes Law Changing How Medicare Sets Prices for Clinical Laboratory Tests; Lab Industry Groups Differ on Which Labs Will Be Winners and Losers

Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists...

Providers, Payers and CMS Gear Up for ICD-10 Implementation, but Will They Be Prepared for Launch by October 1, 2014?

Pathologists and medical laboratory managers have only nine months to prepare their labs for ICD-10 implementation Most clinical laboratory managers and pathologists know that October 1, 2014, is the date for implementation of ICD-10. After that date, each Medicare claim submitted by a medical laboratory must include the ICD-10 code provided by the referring physician. This is a unique reason why clinical laboratories and pathology groups have keen interest in a smooth transition from ICD-9 to...