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CLIA Compliance

McDermott Will & Emery

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

Mintz - Health Care Viewpoints

California Health Care Legislative Update: Winter 2024

Governor Newsom signed over 1300 bills and vetoed almost 190 bills in 2024. Consistent with prior years, in 2024, California enacted multiple laws significantly impacting the health care industry. From artificial intelligence...more

Goodwin

FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests

Goodwin on

On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more

Dickinson Wright

New CMS Proposed Rule Provides Who/What/When for Clinical Laboratory Reporting Requirements Starting January 1, 2016

Dickinson Wright on

Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data”...more

BakerHostetler

Proposed Rule Aims to Refine Stark Regulations and Clarify “Incident To”

BakerHostetler on

On July 15, 2015, the Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2016 Physician Fee Schedule Proposed Rule. In addition to updating several traditional Part B payment policies, the...more

K&L Gates LLP

Potential Stark Changes Ahead

K&L Gates LLP on

On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed regulations governing policies and payments made under the Physician Fee Schedule for calendar year 2016 (the “Proposed Rule”). In...more

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