Rules and Regulations

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September 2025
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Healthcare providers express cash flow concerns under new 340B rebate model

Editor's Note Healthcare providers could experience significant cash flow and operational changes under a new voluntary pilot program that fundamentally alters how the nation's second-largest drug payment program operates, according to an August 11 article in Modern Healthcare. As detailed in the article, The Health Resources and Services Administration announced…

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By: Matt Danford
August 12, 2025
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FDA orders opioid label changes to highlight long-term risks

Editor's Note The US Food and Drug Administration (FDA) is requiring safety labeling changes for all opioid pain medications to better emphasize and explain the risks associated with long-term use, according to a July 31 announcement. These changes follow a May advisory committee meeting where the agency reviewed data on…

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By: Matt Danford
August 6, 2025
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Study: Loophole enables urban hospitals to qualify for rural subsidies

Editor's Note Hundreds of urban hospitals have obtained dual urban-rural Medicare classifications since a 2016 policy change, enabling them to qualify for reimbursement programs intended for rural providers. Fierce Healthcare reported the news August 4. As detailed in the article, a study published in Health Affairs by Johns Hopkins and…

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By: Matt Danford
August 6, 2025
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FDA safety alerts flag cardiac devices

Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…

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By: Matt Danford
August 6, 2025
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FDA issues Class I recall for Philips BiPAP ventilators

Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…

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By: Matt Danford
August 5, 2025
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Nearly half of hospital patient harm events go unreported, OIG reveals

Editor's Note Nearly half of hospital harm events—particularly surgical events—were not captured by reporting systems, according to a July 30 TechTarget report on new findings from the Office of Inspector General (OIG). The OIG report examined 299 harm events experienced by a nationally representative sample of 770 Medicare patients discharged…

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By: Matt Danford
August 4, 2025
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CMS’s newly finalized TEAM payment model holds hospitals accountable for entire surgical episodes

Editor's Note As part of the Centers for Medicare and Medicaid Services (CMS) newly issued 2026 Final Rule, the Transforming Episode Accountability Model (TEAM) will hold hospitals and health systems accountable for the entire episode of care for major surgeries, from admission through 30 days post-discharge. HIT Consultant reported the…

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By: Matt Danford
August 4, 2025
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Brief NIH funding halt sparks backlash

Editor's Note The Trump administration paused new NIH research grants and contracts, prompting widespread concern before abruptly reversing course, according to a July 30 article in Forbes. Citing a separate report in STAT, the article details how the Office of Management and Budget (OMB) directed the NIH to suspend new…

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By: Matt Danford
July 31, 2025
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Judge orders restoration of deleted federal health data

Editor's Note A federal judge has ordered the Trump administration to restore health-related webpages and datasets removed under a January executive order, according to a July 29 article in Medscape. The ruling follows a lawsuit by Doctors for America and the city and county of San Francisco, which argued that…

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By: Matt Danford
July 30, 2025
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Joint Commission to tailor accreditation standards for children’s hospitals

Editor's Note The Joint Commission has launched a new strategy to revise its accreditation and certification programs to better reflect the distinct needs of pediatric care. According to a July 29 announcement, the effort responds to requests from the children’s health community and aims to revise or remove standards that…

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By: Matt Danford
July 30, 2025
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