Tag: Rules and Regulations

FDA announces Class 1 recalls for nerve monitoring system, ambulatory infusion pumps

Editor's Note The US Food and Drug Administration (FDA) designated recalls of Medtronic’s NIM Vital Nerve Monitoring System and Smith Medical’s CADD-Solis Ambulatory Infusion Pumps as Class 1, the most severe category indicating serious risk of injury or death. Reports of false negative responses prompted Medtronic to recall the nerve…

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By: Matt Danford
August 7, 2024
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2025 IPPS payment rule criticized

Editor's Note The American Hospital Association (AHA) criticized new inpatient prospective payment system rates issued August 1 by the Centers for Medicare and Medicaid Services (CMS), citing the potential of financial struggles for hospitals and reduced access for patients, particularly in rural or underserved areas. Under the new rule, most…

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By: Matt Danford
August 6, 2024
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Democratic vice-presidential nominee’s healthcare record examined

Editor's Note Having served six terms in Congress and as Governor of Minnesota since 2018, Democratic vice-presidential nominee Tim Walz has a long history of involvement in healthcare issues. MedPage Today published an overview of his track record on August 6, drawing on sources including ABC News, Star-Tribune, and the…

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By: Matt Danford
August 6, 2024
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1,000 California surgeries cancelled amid CRNA credentialing confusion

Editor's Note A CMS citation for immediate jeopardy this past June allegedly resulted in the cancellation of nearly 1,000 surgeries at Doctors Medical Center in Modesto, California, according to a July 30 article in Becker’s ASC Review. Citing a July 26 letter from California Assemblymen Heath Flora and Juan Alanis…

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By: Matt Danford
August 2, 2024
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"Tweener" hospitals eye financial relief after Supreme Court ruling

Editor's Note The Supreme Court’s recent “Chevron” ruling could offer additional financial security to hundreds of so-called "tweener" rural hospitals—those too large to be considered critical access hospitals but too small to be rural referral centers. Modern Healthcare reported the news July 29. According to the article, critical access hospitals,…

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By: Matt Danford
August 1, 2024
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Healthcare industry groups criticize federal cybersecurity reporting rule

Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…

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By: Matt Danford
July 9, 2024
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Justice Department announces nationwide action on healthcare fraud enforcement

Editor's Note On June 27, The Justice Department announced the 2024 National Health Care Fraud Enforcement Action, leading to criminal charges against 193 defendants, including 76 medical professionals across 32 federal districts in the U.S. for their involvement in various health care fraud schemes. These schemes accounted for approximately $2.75…

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By: Matt Danford
July 3, 2024
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New requirements for ASCs on life safety, patient rights effective August

Editor's Note Starting August 1, ambulatory surgical centers (ASCs) will need to comply with new and revised requirements for Life Safety Code® and patient rights, a June 26 news update from The Joint Commission reports. These updates align with the Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage.…

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By: Tarsilla Moura
July 3, 2024
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Supreme Court decision could lead to legal challenges to payments, risks to healthcare regulation

Editor's Note Food and Drug Administration (FDA) regulations are at risk, and legal challenges to Medicare payments are likely to rise following the Supreme Court’s overturning of the 40-year-old legal precedent Chevron deference, according to a June 28 report in Becker’s Hospital Review. "Chevron deference is the principle that when…

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By: Matt Danford
July 2, 2024
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Study: Federal antitrust action minimal relative to number of hospital mergers

Editor's Note Federal regulation of hospital mergers is inadequate, according to an April antitrust enforcement study scheduled to be published by the American Economic Association. According to a June 14 report in Modern Healthcare, researchers at universities including Harvard and Yale analyzed insurance claims data from Aetna, Humana, and UnitedHealthcare,…

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By: Matt Danford
June 27, 2024
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