ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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Articles and Reports
Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
OIG Report on Lab Testing Should Prompt Compliance Review
Genetic testing now accounts for 43 percent of all Medicare Part B laboratory spending
FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
PAMA Cuts Loom and New Lab Reporting Deadline Nears, Both on January 1
However, a proposed bill called the RESULTS Act is racing to thwart the cuts to lab test reimbursement rates
Is Prior Authorization Reform on the Horizon?
Government reform and payer streamlining may reduce the burden on healthcare providers, but laboratories should remain vigilant
The Success of AI in Lab Billing and Coding Hinges on Good Data
Two revenue cycle management experts explain opportunities that clinical laboratories have with artificial intelligence
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Healthcare Fraud Takedown Reveals 4 Lessons for Clinical Labs
The $14.6 billion bust by federal prosecutors shows gaps that every laboratory should monitor
Could Labs Adopt a CLIA Framework for Regulating Clinical AI?
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
