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Final Rules Diagnostic Tests

Venable LLP

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

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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

Venable LLP

Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"?

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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). This action...more

Manatt, Phelps & Phillips, LLP

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more

BakerHostetler

FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

Holland & Knight LLP

FDA Announces Final Regulation Governing Laboratory Developed Tests

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The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more

Goodwin

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

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On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products...more

Goodwin

FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

Goodwin on

On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

Holland & Knight LLP

CMS Issues 2023 Medicare Physician Fee Schedule Final Rule

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The Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Physician Fee Schedule (PFS) Final Rule on Nov. 1, 2022, which impacts Medicare Part B payments starting on Jan. 1, 2023....more

Dorsey & Whitney LLP

CMS Give Clinical Labs Reporting Deadline Extension

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Clinical laboratories have until May 30, 2017 to make required reports to the Centers for Medicare & Medicaid Services (“CMS”) regarding payment rates paid by private payors for certain diagnostic tests and the volume of such...more

Epstein Becker & Green

CMS Releases Final Rule Implementing Reforms to Medicare CLFS Payment Rates Under PAMA

On June 23, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule implementing Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which established a new payment methodology for...more

King & Spalding

Also In The News - Health Headlines - November 2015

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CMS Publishes Medicaid Access Final Rule – CMS published a Final Rule in the Federal Register today, November 2, 2015, that implements a process for states to determine whether Medicaid payments satisfy what is known as the...more

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