Rules and Regulations

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January 2025
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Federal regulations require written consent for pelvic exams at hospitals, medical schools

Editor's Note New federal guidelines require obtaining written informed consent before conducting pelvic and other sensitive medical examinations, according to an April 2 Associated Press report. The new guidance from the US Department of Health and Human Services focuses specifically on medical students, nurse practitioners, and physician assistants performing breast,…

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By: Matt Danford
April 15, 2024
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Annual CMS rules support underserved, under-resourced communities, promote value-based care

Editor's Note Addressing social determinants of health (SDOHs), strengthening emergency preparedness, and improving maternal heath are among the top priorities of the fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) rules released April 10. These and other efforts aim to…

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By: Matt Danford
April 12, 2024
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Medical error initiative from Joint Commission affiliate NQF targets preventable harm, “never events”

Editor's Note Designed to address high rates of preventable medical errors, a new initiative from The National Quality Form (NQF), an affiliate of The Joint Commission, will modernize criteria for what constitutes a Serious Reportable Event (SRE) and align standards for reporting such events across different accountability systems. Dubbed “Focus…

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By: Matt Danford
April 11, 2024
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EPA rule to limit dangerous emissions from medical sterilization plants

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Editor's Note The Environmental Protection Agency (EPA) has finalized a rule to reduce chloroprene and ethylene oxide emissions that will impact over 200 chemical plants across the nation, including medical sterilization plants, according to an April 10 report from USA Today. Under the new rule, the EPA will cut more…

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By: Brita Belli
April 11, 2024
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FDA approves new antibiotic for staph, other infections

Editor's Note The US Food and Drug administration approved Zevtera for treating Staphylococcus aureus bacteremia (SAB) bloodstream infections, which are often acquired in healthcare settings. In the April 3 announcement, the agency notes the new antibiotic Zevtera (ceftobiprole medocaril sodium for injection) is effective for SAB-infected patients with right-sided infective…

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By: Matt Danford
April 4, 2024
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Private payers profit by delaying medical claims

Editor's Note Private payers initially deny reimbursement on 15% of claims, only to later approve more than half of those initial denials, according to a national survey of healthcare institutions published March 21 by Premiere, Inc. Additionally, the denied claims on average tend to be more prevalent for higher-cost treatments…

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By: Matt Danford
April 4, 2024
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New hope for Black kidney disease patients awaiting organ transplants

Editor's Note A standard kidney function test has been underestimating the seriousness of disease in Black patients, delaying their eligibility for transplants, The Associated Press reported March 31. Now, that test is changing – and Black patients awaiting kidneys are moving up the list.  Among other factors, transplant eligibility is…

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By: Brita Belli
April 1, 2024
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FDA warning: unapproved topical analgesics potentially dangerous

Editor's Note The US Food and Drug Administration (FDA) advises consumers to avoid topical analgesics marketed in violation of federal law by six different companies, including: TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9% SeeNext Venture,…

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By: Matt Danford
March 29, 2024
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Proposed federal rule would require hospitals, health systems to report cyberattacks

Editor's Note The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency (CISA) proposed a new rule that would require hospitals and health systems to report any cyberattacks or ransomware attacks to the agency within 72 hours and any ransomware payments within 24 hours.  The healthcare sector is one of…

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By: Brita Belli
March 28, 2024
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Surglogs, AAAHC partner on digital accreditation standards for better compliance

Editor's Note Surglogs, a leading regulatory and accreditation platform in the healthcare industry, is partnering with the Accreditation Association for Ambulatory Health Care (AAAHC) in a "strategic collaboration," a March 13 press release reports. This collaboration marks a significant advancement in the accessibility of AAAHC accreditation standards, as they will…

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By: Tarsilla Moura
March 27, 2024
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