A new analysis finds that policy and payment gaps are limiting access to diagnostics, with nearly half the world lacking adequate testing and reimbursement lagging behind advances in precision therapies.
AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.
The ACLA and HealthTrackRx sued the FDA, arguing that the agency’s new LDT rule improperly classifies lab testing services as medical devices.
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Senator Rand Paul announced a resolution to repeal the FDA’s LDT Final Rule, arguing it oversteps authority and threatens medical innovation.
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The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.
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ADLM released the results of a survey the organization conducted to determine how the FDA’s proposed LDT rule would impact patient care.Â
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Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA’s proposed rule to regulate LDTs believe it will hurt their labs.
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CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.
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CMS and the CDC issued Final Rulemaking [CMS-3326-F] to update the CLIA fees and clarify the CLIA fee regulations.
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The FDA has issued proposed LDT rulemaking. Laboratories have an opportunity to make comments before it becomes official.
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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 issued a statement supporting the U.S. Congress’ exclusion of the VALID Act from its 2023 Omnibus Bill.
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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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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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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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The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
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The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
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