News & Analysis as of

Clinical Laboratories Proposed Rules Centers for Medicare & Medicaid Services (CMS)

McDermott Will & Schulte

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

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

McDermott+

The Ongoing Poker Game Between Congress and FDA: Who Will Win?

McDermott+ on

Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more

Bass, Berry & Sims PLC

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

Bass, Berry & Sims PLC on

This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Mintz - Health Care Viewpoints

Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

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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