AMP Awards Pathologist for Role in Laboratory-Developed Test Litigation
The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.
Category: Compliance
Compliance
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Compliance
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LDT Ruling Reversing Regulations Marks a Pivotal Moment for Labs
A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.
Compliance
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ACLA Files Suit over FDA’s LDT Final Rule
The ACLA and HealthTrackRx sued the FDA, arguing that the agency's new LDT rule improperly classifies lab testing services as medical devices.
FDA Takes Shot Across the Bow with LDT Rulemaking
The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
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HHS OIG: Labs with Questionably High Billing for Add-On Tests Warrant Further Scrutiny
Certain labs billed Medicare Part B for questionably high levels of add-on tests alongside COVID-19 tests in 2020.
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AACC Statement on Exclusion of VALID Act from Omnibus Bill
AACC issued a statement supporting the U.S. Congress’ exclusion of the VALID Act from its 2023 Omnibus Bill.
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AMP Commends Congress for Nixing VALID Act
The Association of Medical Pathology (AMP) applauded Congress for not including the VALID Act in the Consolidated Appropriations Act of 2023.
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AACC Urges Cutting VALID Act to Preserve Patient Access to LDTs
The AACC is urging clinical lab professionals to write to their legislators to keep the VALID Act out of a Fiscal Year 2023 budget agreement.
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Stop the VALID Act, AMP Urges
AMP is urging medical organizations to contact their elected officials to remove the VALID Act from a 2023 “omnibus” appropriations bill.
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FDA Updates COVID-19 Test Policy
The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
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CMS Proposes Rule to Update CLIA Fees & Regulations
The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
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Theranos Whistleblowers to Give Fireside Chat at AACC 2022
Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
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Medical & Patient Communities Urge Congress to Stop VALID Act
The AACC joins more than 100 other organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act.
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Do We Really Need VALID Act Regulations?
In CLP’s July cover story, we’re examining how the proposed VALID regulations will affect the laboratory industry and society as a whole.
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Fast Facts: Your Guide to the VALID Act
The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.
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Do Laboratory-Developed Tests Have a Future?
As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
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CAP Files Amicus Brief in Support of No Surprises Act Lawsuit
The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
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Accelerator Facility Launched for Clinical Lab Tests
To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
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