Regulations/Legal
Report: Healthcare ransomware compromises millions of patient records, costs billions in downtime
Editor's Note Between 2018 and 2024, ransomware attacks on US healthcare organizations compromised nearly 89 million patient records and resulted in downtime costing an estimated total of $21.9 billion, according to a December 18 report from Comparitech. The report tallies 654 total ransomware incidents during this period targeting hospitals, clinics,…
Proposed tariffs, stricter immigration policies threaten healthcare workforce, supply chain
Editor's Note Immigration and trade policies proposed by President-elect Donald Trump could exacerbate challenges with healthcare staff and medical supply chains, according to recent reporting from Modern Healthcare and The Hill. As detailed by Modern Healthcare, stricter immigration policies could impede efforts to recruit skilled international workers, exacerbating gaps in…
Mastering CMS regulations: How to ensure a finding-free Joint Commission survey
Takeaways • Requirements for improvement and condition level deficiency findings have been trending up in recent The Joint Commission surveys. • The scoring trends and OR hot spots focus on infection control, medication management, national patient safety goals, post-surgical electronic health record tracers, and transplant (tissue) safety. • Federal regulations,…
Surgical legislation advocacy focuses on safety, access
Carrie Zlatos, chief of legislative and political affairs at the American College of Surgeons (ACS), says: “Surgeons are the only people trained to provide surgery—life-saving care. They are an essential element of a community-based healthcare system. Regardless of where you live, everyone should have access to full quality surgical care.”…
FDA designates Class 1 recalls for balloon catheters, radiographic markers
Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…
Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance
Editor's Note Robotic-assisted surgical procedures are no longer futuristic—they are becoming a mainstay in modern ORs. While Intuitive Surgical’s da Vinci system has led the market since 2001, competitors Medtronic and Zimmer Biomet are building innovative portfolios to challenge its dominance, MarketBeat December 12 reports. Medtronic’s Hugo Robotic Assisted Surgery…
Anthem’s anesthesia time limit policy, reversal sparks new legislation
Editor's Note Anthem Blue Cross Blue Shield recently reversed its controversial plan to impose time limits on anesthesia coverage after intense backlash from the medical community, including anesthesiologists and patient advocates. The policy, aimed at curbing alleged overbilling, would have restricted payments based on average surgery times, a move critics…
Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion
Editor's Note Certain medical bills reclassifying minor procedures as “surgery” are driving up costs and causing confusion among patients, KFF Health News December 13 reports. Cases such as a $414 charge for a splinter removal with tweezers and a $469 charge for freezing a skin tag highlight how CPT codes…
Antitrust guideline withdrawal could dampen M&A, boost uncertainty for provider joint ventures
Editor's Note In a move that could hinder provider-led joint ventures and increase regulatory uncertainty, the Federal Trade Commission (FTC) and the Justice Department have withdrawn antitrust guidance issued in 2000. Modern Healthcare reported the news on December 16. Passed in a 3-2 vote, the decision eliminates previously relied-upon safe…
Infusion pump problems prompt early FDA safety warning
Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…
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