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Healthcare › CLIA › Clinical Laboratories

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Gardner Law on

In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Nelson Mullins Riley & Scarborough LLP

CMS Launches Electronic CLIA Certificate Rollout

Nelson Mullins Riley & Scarborough LLP on

On March 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that it will begin sending electronic Clinical Laboratory Improvement Amendments (CLIA) certificates to those laboratories that opt on their CLIA...more

Polsinelli

FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

Polsinelli on

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating...more

King & Spalding

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

King & Spalding on

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

Foley & Lardner LLP

Navigating the Diagnostic Commercialization Process

Foley & Lardner LLP on

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Latham & Watkins LLP

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

Latham & Watkins LLP on

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

Foley & Lardner LLP

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Foley & Lardner LLP on

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Mintz - Health Care Viewpoints

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

Mintz - Health Care Viewpoints on

Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more

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