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Regulatory Requirements › Centers for Medicare & Medicaid Services (CMS) › CLIA

Foley & Lardner LLP

Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule

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A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more

McDermott Will & Schulte

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

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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 Will & Schulte

What the New CLIA Rules Mean for Labs and At-Home Testing

McDermott Will & Schulte on

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...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

Nelson Mullins Riley & Scarborough LLP

CMS Delays Clinical Laboratory Proficiency Testing Rulemaking by a Year

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The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year. ...more

Mintz - Health Care Viewpoints

CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing

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In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more

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