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Reporting Requirements › Proposed Rules › CLIA

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

McDermott Will & Emery on

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Mintz - Health Care Viewpoints

Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

Mintz - Health Care Viewpoints on

Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the...more

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