CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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Software as a Medical Service, or SaMS, Takes Spotlight in New CMS Proposal
Clinical labs have until Aug. 31 to submit public comments about the anticipated changes
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
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Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
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CMS Proposes Modest Increase to Hospital IPPS Rates
Unsurprisingly, the American Hospital Association and other industry groups don’t think that increase is anywhere near adequate.
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CMS Launches Free Medicare Coverage of OTC COVID-19 Rapid Antigen Tests
Starting April 4, Medicare beneficiaries can get eight free tests per month for each month the public health emergency remains in effect.
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