Arkansas Pathology Lab and Owners to Pay $30 Million to Settle Kickback Allegations
The settlement resolves claims that Advanced Pathology Solutions provided illegal incentives to gastroenterology practices and performed unnecessary medical testing.
Category: Compliance
Compliance
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Compliance
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Lab Owner Charged with $46 Million Medicare Billing Fraud for Tests Never Performed
The owner of an Oregon clinical laboratory allegedly submitted tens of millions in fraudulent claims to Medicare Advantage plans for laboratory testing services that were never ordered or performed.
Compliance
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FDA Withdraws Final Rule Regulating Lab-Developed Tests as Medical Devices
The action follows a federal court order that vacated the 2024 rule, reinstating FDA’s prior policy of enforcement discretion for laboratory-developed tests.
AMP Celebrates Decision to Vacate FDA Rule on LDT Regs
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
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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.
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ADLM Calls on HHS to reinstate CLIAC
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
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Is There a Smart Path to Regulating Laboratory Developed Tests?
Xifin’s CEO sees a window of opportunity for lawmakers to modify the Final Rule on LDTs that will be a win-win for the industry and patients.
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ADLM Says FDA’s LDT Rule Will Hinder Patient Care for the UnderservedÂ
The FDA’s new LDT rule could severely limit access to vital diagnostics, particularly in rural and marginalized communities, ADLM says.
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AMP Challenges FDA’s LDT Rule, Advocates for CLIA Modernization
AMP filed a lawsuit against the FDA for its new rule regulating LDTs as medical devices, advocating instead for modernizing CLIA regulations.
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Labguru Achieves SOC 2 Type 2 Compliance
Labguru completed the SOC 2 Type 2 examination, demonstrating a commitment to high standards of security, privacy, and confidentiality.
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ADLM Says FDA’s LDT Final Rule Will Impede Fight Against Drug Epidemic
An ADLM survey found that the FDA’s LDT final rule will likely reduce patient access to crucial tests, despite exemptions to mitigate this.
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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.
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Senator Rand Paul Introduces Resolution to Repeal FDA’s LDT Final Rule
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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FDA Announces Final Rule on LDT Regulation
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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Clinical Labs Say FDA’s LDT Rule Would Hinder Pediatric Care
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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Labs Express Concern about Testing Access if FDA Regulates LDTs
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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Is There a Balancing Point for LDT Regulations?
CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.
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CMS and CDC Issue Final Rulemaking Updating CLIA Fees
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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