Department of Health and Human Services (HHS), Reporting Requirements, Clinical Laboratories

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on 2/27/2025

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

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

McDermott Will & Emery on 2/3/2025

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

Laboratory Group Challenges CMS’s Implementation of Clinical Laboratory Commercial Data Reporting Requirements

King & Spalding on 12/22/2017

On December 11, 2017, the American Clinical Laboratory Association (ACLA) filed suit on behalf of its membership against the Secretary of HHS, challenging the Secretary’s implementation of the Protecting Access to Medicare...more

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on 10/12/2015

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

Department of Health and Human Services (HHS) › Reporting Requirements › Clinical Laboratories

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

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

Laboratory Group Challenges CMS’s Implementation of Clinical Laboratory Commercial Data Reporting Requirements

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

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