Senator Honored for Efforts to Improve Pediatric Lab Testing
The ADLM honored senator Shelley Moore Capito for advancing pediatric reference intervals, citing her support for related provisions in Senate appropriations bills for FY 2025 and 2026.
Category: Compliance
Compliance
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Compliance
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New Jersey Lab Must Repay $3.4 Million to Medicaid for Billing Violations
State audit finds the lab billed for drug tests without required physician signatures in nearly a quarter of reviewed instances.
Compliance
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Lab CEO, Physicians, Marketers Pay $6M to Settle Kickback Allegations
Settlement resolves False Claims Act litigation alleging illegal payments disguised as management service organization distributions.
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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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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