Editor's Note Since February 2024, changes to the Registrant Validation Toolset from the Drug Enforcement Administration (DEA) have introduced new hurdles for healthcare organizations, MedTrainer October 2024 reports. The updates, which aim to prevent fraud by adding multi-factor authentication, are causing compliance challenges during primary source verification (PSV). Credentialers are…

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Editor's Note CMS has taken the next steps in making prescription drugs more affordable for Medicare recipients, according to an October 9 report from The US Department of Health and Human Services (HHS). The proposed Medicare $2 Drug List Model, developed in line with President Biden’s Executive Order 14087, aims…

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Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…

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Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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Editor's Note The US Food and Drug Administration (FDA) has deemed the recall of Sentec Percussionaire’s Phasitron 5 In-Line Valve—a component of the manufacturer’s Intrapulmonary Percussive Ventilation (IPV) therapy system—a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s October 2…

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Editor's Note This fall 2024 study published by the CATO Institute found that repealing Certificate-of-Need (CON) laws for ambulatory surgical centers (ASCs) would significantly increase the number of ASCs, improving patient access to affordable and high-quality care. By examining six states that repealed ASC-specific CON laws between 1991 and 2019,…

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Editor's Note The October 1 vice presidential debate showcased sharp divisions between the candidates on healthcare policy, focusing primarily on the future of the Affordable Care Act (ACA) and reproductive rights. A summary published October 2 in Stat details how Sen. JD Vance (R-Ohio) proposed changes that could allow insurers…

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Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…

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Editor's Note The shuttering of a critical Baxter International manufacturing plant in North Carolina due to Hurricane Helene could put significant stress on already strained healthcare supply chain, according to an October 1 report in Axios. According to the article, the facility is a critical production center for produces intravenous…

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Editor's Note The Health Infrastructure Security and Accountability Act, introduced by Senators Ron Wyden (D-Ore.) and Mark Warner (D-Va.), proposes new mandatory cybersecurity standards for the healthcare sector, with oversight from the Department of Health and Human Services (HHS), Nextgov/FCW reported September 26. The bill, which amends the Health Insurance…

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