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Jan 8, 2025 | 
mondaq.com | Gregory E. Fosheim |Ashley Ogedegbe
New regulations under the Clinical Laboratory ImprovementAmendments (CLIA) introduced updated proficiency testing (PT) andPT referral rules that are now in effect. Although the regulationsbecame effective on July 11, 2024, the final rule on PT RegulationsRelated to Analytes and Acceptable Performance (CMS-3355-F), issued by the Centers forMedicare & Medicaid Services (CMS), was not implemented untilJanuary 1, 2025.
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Jan 6, 2025 | 
jdsupra.com | Gregory E. Fosheim |Ashley Ogedegbe
OverviewNew regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024, the final rule on PT Regulations Related to Analytes and Acceptable Performance (CMS-3355-F), issued by the Centers for Medicare & Medicaid Services (CMS), was not implemented until January 1, 2025.
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Mar 29, 2024 | 
jdsupra.com | Paul S. Gadiock |Ashley Ogedegbe |James Ravitz
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM (iCGM) designed for individuals 18 years and older who do not use insulin. Previously, CGMs were only available by prescription and were primarily designed for diabetes management.
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Nov 15, 2023 | 
employeebenefitsblog.com | Ashley Ogedegbe
States Move to Standardize Healthcare Licensing Requirements Numerous states—including Alaska, Wisconsin, Ohio and Oregon—have been busy finalizing rulemaking and legislation advancing hybrid healthcare models, modernizing licensure infrastructures and incentivizing telehealth. What have these states been up to over the last month? Read more here.
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Nov 6, 2023 | 
jdsupra.com | Marshall Jackson |Ashley Ogedegbe
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.
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Nov 3, 2023 | 
natlawreview.com | Moorari Shah |A.J. Dhaliwal |Marshall Jackson |Ashley Ogedegbe
According to Bleeping Computer, crypto fraud researchers at ZachXBT, and MetaMask developer Taylor Monahan have reported that on October 25, 2023, “hackers have stolen $4.4 million in cryptocurrency using private keys and passphrases stored in stolen LastPass databases.”According to a post by ZachXBT, “Just on October 25, 2023, alone another~$4.4M was drained from 25+ victims as a result of the LastPass hack.
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Oct 27, 2023 | 
natlawreview.com | Cybersecurity Robinson Cole |Dale Van Demark |Ashley Ogedegbe |Kathryn Rattigan
According to a press release, Personal Touch, a home health company located on Long Island, has reached a settlement with New York Attorney General Letitia James for $350,000 for a data breach that occurred in January of 2021 when a Personal Touch employee “opened a malware-infected file attached to a phishing email that allowed a hacker to gain access to Personal Touch’s network and collect patient and employee records from an unencrypted server.” The incident compromised the personal...
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Oct 27, 2023 | 
jdsupra.com | Ashley Ogedegbe |Dale Van Demark
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate the delivery of virtual care.
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Sep 1, 2023 | 
jdsupra.com | Emily Cook |Tony Maida |Ashley Ogedegbe
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS). We also review several major reimbursement regulatory updates and a recent advisory opinion issued by the Office of the Inspector General (OIG).
Please see full Newsletter below for more information.
Download PDF
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Apr 1, 2023 | 
natlawreview.com | Ashley Ogedegbe
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