Join the FDA’s CDRH Real-World Evidence Public Meeting Date and Time: January 30, 2025; 9:00 am - 12:00 pm (ET)

https://www.surveymonkey.com/r/RealWorldEvidenceUpdate?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting to share the Center for Devices and Radiological Health’s (CDRH) recent Real-World Evidence (RWE) program updates and activities. As part of CDRH’s Medical Device User Fee Amendments 2022 (MDUFA V) commitments, the Center continues to develop real-world data (RWD) and RWE methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use and new clearance/approval of new devices. Meeting Date: Thursday, January 30, 2025,11:00 a.m. – 12:00 p.m. ET Location: Webcast Registration Deadline: Tuesday, January 29, 2025, at 4:00 p.m. ET

RegenMedEd Roundtable with FDA’s Office of Therapeutic Products (OTP) January 30, 2025 +++

https://www.fda.gov/news-events/otp-events-meetings-and-workshops/regenmeded-roundtable-fdas-office-therapeutic-products-otp-01302025?utm_medium=email&utm_source=govdelivery February Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma February 19, 2025 February 19, 2025 https://www.fda.gov/news-events/public-webinar-fda-review-biologics-license-applications-blood-and-source-plasma-02192025?utm_medium=email&utm_source=govdelivery Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development February 25, 2025 Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development February 25, 2025 https://www.fda.gov/news-events/otp-events-meetings-and-workshops/cell-therapies-and-tissue-based-products-public-workshop-generating-scientific-evidence-facilitate?utm_medium=email&utm_source=govdelivery

Inside STAT's investigations of UnitedHealth Group

The killing of UnitedHealthcare CEO Brian Thompson sparked extraordinary public interest in the health insurance industry. But much of the outcry centered not on the killing itself but on health care executives, and on the companies' practices themselves. For the last two years, STAT journalists reviewed thousands of pages of documents and connected with dozens of clinicians to reveal the untold human cost of UnitedHealth’s grip on the U.S. health system. In an exclusive video, they unpack exactly how UnitedHealth amassed so much power, and why it's more important than ever to pay attention to the company.

Fast Facts - Neurology & neuroscience

https://www.news-medical.net/whitepaper/20241217/Fast-facts-Neurology-neuroscience.aspx This collection of eBooks is dedicated to the fields of Neurology and Neuroscience, offering a carefully curated selection of Fast Facts that delivers in-depth, accessible knowledge on various neurological conditions and their management. Designed for healthcare professionals, researchers, and students, these resources provide essential insights into complex neurological disorders, making them invaluable tools for enhancing understanding and improving patient care

Fast Facts - The ABC of oncology

https://www.news-medical.net/whitepaper/20241217/Fast-facts-The-ABC-of-oncology.aspx This collection of oncology eBooks is where expert knowledge meets accessible learning, covering a wide range of topics essential for patients, healthcare professionals, and anyone seeking to understand the complexities of cancer and its treatment. Each eBook is curated to provide trusted, accessible, and concise medical information making it easy to for anyone to understand crucial concepts and developments in the field of oncology. Whether you are dealing with a specific cancer type, navigating treatment options, or interested in the latest research, these eBooks are an invaluable resource.

Fast Facts - Hematology

https://www.news-medical.net/whitepaper/20241217/Fast-facts-Hematology.aspx This collection of hematology eBooks is designed to provide reliable knowledge and practical insights into various blood disorders. Titles like Fast Facts for Patients: Follicular Lymphoma" and "Fast Facts: Follicular Lymphoma" are used as sources of trustworthy and relevant information that can help facilitate meaningful conversations between patients and their healthcare providers, or for healthcare professionals to get up to speed quickly on a topic.

Fast Facts - Women's health

https://www.news-medical.net/whitepaper/20241217/Fast-facts-Womens-and-childrens-health.aspx This collection of eBooks on Women's Health aims to empower with knowledge, featuring a selection of guides on health topics crafted by experts to provide accessible and reliable information. Whether you are seeking insights into sexual and reproductive health, managing menopause, understanding urogenital atrophy, or navigating the journey of early breast cancer, these eBooks are designed to support and guide you.

Fast Facts - Pneumology

https://www.news-medical.net/whitepaper/20241217/Fast-facts-Pneumology.aspx This collection of eBooks is dedicated to Pneumology, providing patients and healthcare professionals with the latest information and insights into respiratory health. It features authoritative resources such as "Fast Facts for Patients: Non-small Cell Lung Cancer" and "Fast Facts: Non-Small Cell Lung Cancer," which provide the latest medical information of trusted, accessible, and concise medical information empowering readers to navigate this critical area of healthcare with confidence.

Engineering Safety into Practice through Implementation of the EHR SAFER Guides, January 21, 12-1 PM ET January 21, 2025 12:00 PM - 1:00 PM EST

https://cma.ahrq.gov/cma/welcome.jsp?code=naajan2025 As the modern healthcare delivery system continues to evolve, the safe and effective design, development, implementation, and use of electronic health records (EHRs) as the primary means of patient data collection, storage, retrieval, and communication becomes more apparent. The safety of our patients, workforce, and health care system requires a shared commitment and responsibility to evidence-based practices known to help the health IT community improve the safety and safe use of information systems vital to health care delivery. The Safety Assurance Factors for EHR Resilience (SAFER) guides are designed to help healthcare organizations of all sizes from individual practices to large hospital systems meet that responsibility by conducting proactive self-assessments to evaluate the safety and effectiveness of their electronic health record (EHR) implementations. The 2025 SAFER guides have been updated and streamlined to focus on the highest risk, most commonly occurring issues that can be addressed through technology or practice changes to build system resilience. Join us on January 21, 12:00-1:00 PM ET, for a session on engineering safety with Dean Sittig, PhD and Hardeep Singh, MD, MPH, the authors of the SAFER Guides, as they discuss the development of this latest version and the use of the guides for self-assessments.

Gene-edited pig kidney transplanted into a third person, moving xenotransplants closer to trials Recipient had donated a kidney to her mother, then no human organ could be found for her

https://www.statnews.com/2024/12/17/gene-edited-pig-kidney-transplanted-into-third-person-nyu-langone/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8nJO83j4pQDe-o_bkSywCm1y5E7Cl2wJxJtwYqTcxuQST96nS-6Tzbtt_MyklttEyK84FKjz_TPem6nHcvEHpL0PHXTA&_hsmi=339774288&utm_content=339774288&utm_source=hs_email A record-breaking kidney transplant chain Last week, surgeons at Ohio State’s transplant center set an institutional record for a synchronized chain of kidney transplants. Over two days, they transplanted kidneys from 10 donors into 10 recipients. The “chain” begins with one person donating their kidney to an unknown recipient. Each of the recipients had a loved one whose organ wasn’t a match for them, but which did match with someone else in need of a kidney along the chain. Nationwide, there are currently more than 90,000 people on the transplant waitlist in need of a kidney. “This kidney chain removed ten patients from the transplant waitlist, which will hopefully shorten the wait for others,” Amer Rajab, the surgical director of kidney transplantation who led the chain and performed six of the donor surgeries, said in a press release. The successful transplants from living donors occurred just days after the third completed pig-to-human kidney transplant was announced in New York. https://wexnermedical.osu.edu/mediaroom/pressreleaselisting/ohio-state-20-person-living-kidney-donor-transplant-chain?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--OJN0fznVJZ3icaFQDyz4CWmDS7WJtjPrQt14iBJcLeVXKWR_icoc9tiO9ARaUpXubrrbBtpx3b2x6sQ26ySJTyuBDQg&_hsmi=339774288&utm_content=339774288&utm_source=hs_email

The recommended women’s health screening that rarely happens Every adult woman should be screened for incontinence

https://www.statnews.com/2024/12/23/urinary-incontinence-screening-treatment-womens-health/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-99uXWP1OUSioWsCmktHElc1keYgVaA4H_t9tTNT_HPXMZBqOd60MerOScfroM3h-QxZ240wly7lPAF5JXzJyxIqsTVfw&_hsmi=339774288&utm_content=339774288&utm_source=hs_email Women are supposed to be screened for incontinence. Why aren’t they? Did you know that more than half of adult women in the U.S. live with bladder and/or bowel leaks? Here’s another fact that I didn’t know: Incontinence is a progressive condition, meaning that without treatment, it can get worse. Nearly every relevant professional medical group recommends screening women for incontinence, but it rarely happens. Why? “The reasons are inherent to the fabric of our health care system,” write two physicians in a new First Opinion essay. And there are more consequences than shame or embarrassment: When left untreated, incontinence is associated with major negative health outcomes. Advertisements for adult diapers and other quick fixes may normalize the experience, but effective treatments exist. Read more on why the U.S. health care system needs to think differently about women’s pelvic floor.

Gender-affirming surgery disappeared from the U.S. for decades. Now the field is fighting to keep its gains Theresa Gaffney By Theresa Gaffney

https://www.statnews.com/2024/12/23/gender-affirming-surgery-increased-demand-but-future-access-faces-challenges/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9VQwMIihK77lgKc7xC1pnEwc-YPKZ8b6ldmeMYmH9gtfA3rgSMXChKikHp69HOmxZZ5UUs6sMcZU4XooI3Kv2OKnWlIg&_hsmi=339774288&utm_content=339774288&utm_source=hs_email For patients who receive gender-affirming surgery, the experience can feel like a rebirth. “I decided that the old me would die on the table and then the new me would come up from it,” Wendy Grogan, a trans woman who recently pursued vocal and facial procedures, top surgery, and a vaginoplasty, told me. Grogan is one of thousands of patients in the U.S. who receive gender-affirming surgery each year. The field has remarkably transformed in the past decade since insurance coverage started to open up. But trans people and their medical care have also become a major flashpoint in U.S. politics over the last few years. It’s not the first time trans health care has been clawed back. Gender-affirming surgeries almost disappeared in the U.S. after the country’s first dedicated clinic closed in 1966. Now, patients and clinicians alike are worried about what the future holds for a surgical specialty that’s finally beginning to come into its own. Read more in my story on some of the most impressive and rewarding procedures in medicine. I’m still thinking about one 19-year-old patient I met, pictured above, during his first phalloplasty consultation. (And for a hint at how long it actually takes to get these surgeries — that meeting was a year ago this month, and that person still hasn’t had his first procedure yet.)

Rapid spread of H5N1 bird flu through California dairy herds suggests unknown paths of transmission Experts are skeptical that USDA’s theory of viral spread is telling the whole story

https://www.statnews.com/2024/12/20/california-h5n1-bird-flu-emergency-declaration-avian-flu-spread-dairy-cattle/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9VApBhtqX_hplf5pPTiCBRdbkXT3OrlWCUl6Ld2Blw_M-UGwf0saZioiFColk_zrPPl7R6NkBFjWJYvK-MDvdHzwMrTA&_hsmi=339774288&utm_content=339774288&utm_source=hs_email California scrambling to understand scale of bird flu spread California animal health authorities are now testing milk from all 984 of the state’s dairies on a weekly basis, stepping up its efforts to find new H5N1 infections in cattle. In a call with reporters Friday, California state veterinarian Annette Jones said that the new strategy was implemented two weeks ago, after the virus was found on a farm in Southern California. The majority of the state’s 659 infected herds have been concentrated in the Central Valley. The rapid spread of H5N1 in California has nfectious disease experts questioning how well authorities understand how the virus is moving between farms. Jones said California has dozens of research projects underway to study this question. But she also noted that cows may be asymptomatic for a number of weeks—which could have contributed to infected animals unwittingly being moved to new farms during the early stages of California’s outbreak. The unchecked spread is also leading to new human cases. The California Department of Public Health reported Friday two more H5N1 infections, both in dairy workers, raising the state’s total to 36. State epidemiologist Erica Pan told reporters that health officials have monitored about 5,000 people and tested 130 who had potential symptoms. She also added that officials have been investigating numerous detections of H5N1 at wastewater sites throughout the state, and that at the present time, there is still no evidence of human-to-human transmission. “Almost all of our wastewater testing sites are detecting H5 now,” she said. However, officials suspect that much of what they’re picking up is not live virus, but inactivated bits of viral RNA in pasteurized milk. “We think a lot of our wastewater detections are actually just from residential or other commercial milk dumping,” Pan said. — Megan Molteni

Lawmakers call for curbs on UnitedHealth’s growing empire Casey Ross Bob Herman Tara Bannow Lizzy Lawrence By Casey Ross, Bob Herman, Tara Bannow, and Lizzy Lawrence

https://www.statnews.com/2024/12/23/unitedhealth-group-lawmakers-consider-antitrust-breakup-health-care-giant/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_fudU5Eem-HcWTLNtcpCJ0LlYzvzgMzlCluO3-VBO7gOZvocg43DcrWiOMsY8G3aiwKjpdzBDkS9ce9i-GwPOC9RlGtg&_hsmi=339774288&utm_content=339774288&utm_source=hs_email Democratic lawmakers are calling for aggressive action to curb the increasing market power of UnitedHealth Group, including a possible breakup of a business empire they say is undermining competition, corrupting Medicare, and hurting vulnerable patients. They condemned the targeted killing of Brian Thompson, the CEO of UnitedHealth’s insurance business. But they said the display of resentment and rage that followed was neither new nor surprising at a time when people feel powerless to defend themselves against a company that controls their doctors, their data, and their insurance policies. “For the sake of patients, taxpayers, and independent practices, policymakers should act to prohibit joint ownership of health insurers and their provider subsidiaries, including physicians and pharmacies,” Sen. Elizabeth Warren told STAT. My colleagues’ investigation into UnitedHealthy this year exposed deeply embedded conflicts within its sprawling network of businesses. The latest installment finds that UnitedHealth pays some of the physician practices it owns significantly more than it pays other physician groups in the same market for similar services. https://www.statnews.com/unitedhealth-group-investigation-health-care-colossus-series/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8RoYhfxKrLD_tKREVwIKNCxm_Fgytgexrzn_q2EgJ2N5TQqMCh8fuZBDVtkNap2oMywgeLKcofNtVWAdDwLQoEbwUArQ&_hsmi=339774288&utm_content=339774288&utm_source=hs_email

DIA-US FDA | Navigating Biosimilars: FDA Insights on Development and Lifecycle Management Strategies February 3-4, 2025: Hyderabad, Telangana, India

https://www.diaglobal.org/en/conference-listing/meetings/2025/02/dia-us-fda-biosimilars-workshop-navigating-biosimilars-fda-insights-on-development-and-lifecycle-management-strategies/register#showcontent The U.S. Food and Drug Administration’s (FDA) India Office and the Drug Information Association’s (DIA) India Office will host a 2-day workshop on best practices related to biosimilar product development and regulatory submissions to the FDA, including life-cycle management of approved applications. This joint program offers a unique opportunity for participants to engage with and gain insight from FDA’s Center for Drug Evaluation and Research (CDER) subject matter experts on current regulatory perspectives highlighting a range of topics applicable to biosimilar products. FDA regulators will provide an overview of regulatory requirements for biosimilar and interchangeable biosimilar products. They will also discuss topics covering comparative analytical and clinical data expectations, common deficiency trends in Biological Licensing Applications (BLAs), inspections, post-approval changes, and research and educational efforts about biosimilars for patients and health care providers. Learning Objectives: The objective of this workshop is to share the Agency’s expectations and current thinking on biosimilar and interchangeable product development and life cycle management. The workshop topics are designed to engage participants in active dialogue and to encourage a better understanding of regulatory expectations related to biosimilar and interchangeable biosimilar products. The workshop will focus on the best practices in submitting and managing biosimilar applications, data expectations, challenges in application review and submission, regulatory support mechanisms, and real-world examples experienced by FDA regulators. Featured Topics: Scientific and regulatory expectations for Chemistry, Manufacturing, and Controls (CMC), Comparative Analytical Assessment & Clinical Studies Interchangeability Biosimilar application review process Common review deficiencies Post-approval changes Major 483 observations Best practices and real-world examples Educational efforts for patients and providers, the Purple Book, and other online resources

Bill of the Month

This crowdsourced investigation by KFF Health News dissects and explains your medical bills every month in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. https://kffhealthnews.org/news/tag/bill-of-the-month/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--lURKR7Dj4ejoJg7ZqJ4D5ZTWDuaPqds9__C43lgELjTb0p-XEoA4OSQouYTUS-rfD462lEH4k6jdytJucRwdXFsLK_Q&_hsmi=339602266&utm_content=339602266&utm_source=hs_email

Native American Patients Are Sent to Collections for Debts the Government Owes // How a Duty To Spend Wisely on Worker Benefits Could Loosen PBMs’ Grip on Drug Prices // Employers Press Congress To Cement Health Price Transparency Before Trump’s Return

HEALTH CARE COSTS Native American Patients Are Sent to Collections for Debts the Government Owes By Katheryn Houghton and Arielle Zionts Federal law says Native Americans aren’t liable for medical bills the Indian Health Service promises to pay. Some are billed anyway as a result of backlogs or mistakes from the agency, financial middlemen, or health systems. https://kffhealthnews.org/news/article/native-american-patients-debt-collection-indian-health-service-ihs/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_iwnuE4WOXSTVHgvW7mG1egu70dVWJcTLK93kbSZlANlud6h1Qt6ktd7a6CtSK1Zw3HOIuGCC1h07U2iY_RdJCRclaYg&_hsmi=339602266&utm_content=339602266&utm_source=hs_email How a Duty To Spend Wisely on Worker Benefits Could Loosen PBMs’ Grip on Drug Prices By Arthur Allen As criticism of pharmacy benefit managers heats up, fear of lawsuits is driving some big employers to drop the “Big Three” PBMs — or force them to change. https://kffhealthnews.org/news/article/pbms-pharmacy-benefit-managers-erisa-lawsuit-mark-cuban-cost-plus/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8tPkcvKZnF-tYOqa1Vf9Jli-YksQ0iMrlmnCCAJWRF7mD79vDcwWJvXujXU5g-Oa5h-WzuZ6cW3-VRUG9Ojggkpknr8Q&_hsmi=339602266&utm_content=339602266&utm_source=hs_email Employers Press Congress To Cement Health Price Transparency Before Trump’s Return By Julie Appleby Donald Trump’s first administration advanced rules forcing hospitals and insurers to reveal prices for medical services. Employers don’t want to risk backtracking during Trump’s second administration. https://kffhealthnews.org/news/article/price-transparency-health-care-trump-regulations-hospitals/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8OnCxnhRHg7eH0KCMn2JLVMzl9VUVm9KssgftuM2ioAa5ADdhdM7qbC_HWJ2KRUOjsk9pcXE0g-LmL7uMtEAVQJU_gLw&_hsmi=339602266&utm_content=339602266&utm_source=hs_email

Trump’s Picks for Top Health Jobs Not Just Team of Rivals but ‘Team of Opponents’

TRUMP ADMINISTRATION Trump’s Picks for Top Health Jobs Not Just Team of Rivals but ‘Team of Opponents’ By Stephanie Armour and Julie Rovner The president-elect’s choices to lead the Department of Health and Human Services, as well as agencies such as the National Institutes of Health, FDA, and CDC, hold positions on issues including abortion and vaccination that are often at odds. https://kffhealthnews.org/news/article/trump-rfk-kennedy-health-hhs-fda-cdc-vaccines-covid-weldon/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_BiNEPRVnfhgYy240eFEx-asXLb3dUjz0WF6bHpyCl4yGosGFM_2zp1ajnE4XNWPPlIx-gao7Wj9-Mw99Hj3mA2HlQIA&_hsmi=339602266&utm_content=339602266&utm_source=hs_email Trump Threat to Immigrant Health Care Tempered by Economic Hopes By Vanessa G. Sánchez Donald Trump’s second term is reigniting mistrust in health services among California immigrants, making it harder for community health workers to get people enrolled in Medi-Cal. Yet the president-elect is also seen as someone who could improve their lives with a better economy, even if that means forgoing health care. https://kffhealthnews.org/news/article/california-trump-immigrants-medi-cal-economy-health-care/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8edVeWoL86lt_xmJCsXLQ5wvacrIQcqDcIIRcBUtvCpqITsAjueV_XLVKoXwfvNg6S5w9KYNDiNsuujiqmmdFCeyJ2dg&_hsmi=339602266&utm_content=339602266&utm_source=hs_email

Obamacare Sign-Ups Lag After Trump Election, Legal Challenges // Democratic Senators Ask Watchdog Agency To Investigate Georgia’s Medicaid Work Rule

INSURANCE Obamacare Sign-Ups Lag After Trump Election, Legal Challenges By Julie Appleby The number of new and returning enrollees using healthcare.gov — the federal marketplace that serves 31 states — is well below last year’s as of early December. Also, a Biden administration push to give “Dreamers” access to Obamacare coverage and subsidies is facing court challenges. https://kffhealthnews.org/news/article/obamacare-enrollment-lag-trump-election-legal-challenges/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9FN2kIkgISP_F7ygWiutZQ1aMcmYKvTnjLTJB-PpEbuPSPUWQRJ8MQAzZuFJnXhWdn_b49BgyKFZsLDAtsqczpy-NNwQ&_hsmi=339602266&utm_content=339602266&utm_source=hs_email Democratic Senators Ask Watchdog Agency To Investigate Georgia’s Medicaid Work Rule By Andy Miller and Renuka Rayasam and Sam Whitehead A group of Democratic senators asked the Government Accountability Office to examine a Georgia program that requires some Medicaid enrollees to work, study, or volunteer 80 hours a month for coverage. They cited KFF Health News’ reporting, which has documented the program’s high costs and low enrollment. https://kffhealthnews.org/news/article/georgia-medicaid-word-requirement-democrats-gao-investigate/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--1KfnATsnqauG8h4-KT5QA4--gjf4J6K7qDElcebuiQd_JBJd7_BqtxrtdiZ8xSZsHz90fvgmZOzi-9oowyew7PFSQCA&_hsmi=339602266&utm_content=339602266&utm_source=hs_email

End-of-Year Chaos on Capitol Hill Episode 377 December 19, 2024

https://kffhealthnews.org/news/podcast/what-the-health-377-congress-chaos-budget-december-19-2024/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_m45OsEnZwp0Eid1VPMoGfrwtb2Oed0XGA2GtKJlNsj8cCbzHyNKnOsWT6LmE8TUJruiTv_EE7dKfaKdvgXZNOna1kSA&_hsmi=339602266&utm_content=339602266&utm_source=hs_email KFF Health News' 'What the Health?': End-of-Year Chaos on Capitol Hill Democrats and Republicans in the House and Senate successfully negotiated an enormous end-of-Congress health package, including bipartisan efforts to address prescription drug prices — only to see it blown up at the last minute after Elon Musk and President-elect Donald Trump applied pressure. Meanwhile, the Supreme Court accepted its first abortion-related case of the term, and the attorney general of Texas sued a doctor in New York for prescribing abortion pills to a Texas patient. Alice Miranda Ollstein of Politico, Jessie Hellmann of CQ Roll Call, and Victoria Knight of Axios join KFF Health News’ Julie Rovner to discuss these stories and more. Also this week, Rovner interviews KFF President and CEO Drew Altman about what happened in health policy in 2024 and what to expect in 2025.

Hypoxemia after Emergency Intubation Christian Bohringer, MBBS and Hong Liu, MD | December 18, 2024

https://psnet.ahrq.gov/web-mm/hypoxemia-after-emergency-intubation Hypoxemia after Emergency Intubation After drowning in a pool, a 19-month-old child arrived at the ED in respiratory distress, requiring intubation and mechanical ventilation. The patient’s SpO2 did not improve after the first intubation attempt; after a second attempt, it was discovered that the mechanical ventilator had not been connected to an oxygen source. The WebM&M commentary discusses approaches to improving safety during emergency intubation, such as capnography confirmation, standardized algorithms to assess post-intubation hypoxia, and simulation training to improve intubation skills.

Importance of Following Safe Practices for Infant Feeding and Handling Expressed Breast Milk Marla Shauer, PhD, CNM, MSN, Diana Guzman Perez, MS, Brenda Chagolla, RN, PhD, CNS, FACHE | December 18, 2024

https://psnet.ahrq.gov/web-mm/importance-following-safe-practices-infant-feeding-and-handling-expressed-breast-milk Importance of Following Safe Practices for Infant Feeding and Handling Expressed Breast Milk Infant feeding presents an opportunity for hospital and community staff to review safety processes around feeding of expressed breast milk or the provision of infant formula. This WebM&M commentary describes safe infant feeding practices and strategies to avoid breast milk feeding errors or the provision of expired feeding products.

Management of CSF Leaks After Elective Spine Surgery: Routine Laminectomy Leads to Fatal Discitis and Sepsis Jose A Castillo Jr, MD, Richard Price, MD, PhD, Kee D Kim, MD | December 18, 2024

https://psnet.ahrq.gov/web-mm/management-csf-leaks-after-elective-spine-surgery-routine-laminectomy-leads-fatal-discitis Management of CSF Leaks After Elective Spine Surgery: Routine Laminectomy Leads to Fatal Discitis and Sepsis In this WebM&M Spotlight Case with CE/MOC, an older man underwent L4-5 decompressive lumbar laminectomy and discectomy, which was complicated by intraoperative durotomy. At a follow-up visit, he reported clear drainage from the surgical site and the surgeon suspected a cerebrospinal fluid (CSF) leak. Despite conservative management at home, his condition worsened over several weeks before being readmitted with discitis, osteomyelitis and sepsis, resulting in his death 50 days after the operation. The commentary provides an overview of the clinical manifestations of intraoperative durotomy, intra- and post-operative management strategies to address intraoperative durotomy and CSF leaks, and approaches to ensuring patient safety during spine surgery.

Neurological Red Flags: A Missed Stroke after Intermittent Episodes of Dizziness and Headache Jonathan A. Edlow, MD, FACEP | December 18, 2024

https://psnet.ahrq.gov/web-mm/neurological-red-flags-missed-stroke-after-intermittent-episodes-dizziness-and-headache Neurological Red Flags: A Missed Stroke after Intermittent Episodes of Dizziness and Headache In this WebM&M Spotlight Case with CE/MOC, a patient in his mid-30s presented to the emergency department (ED) with three weeks of intermittent left-sided headaches, balance issues, and one brief episode of difficulty speaking and moving. On exam, the patient had normal vital signs, neurologic exam, and initial imaging; he was discharged from the ED without consultation from neurology. A few hours later, he suffered a stroke due to left posterior cerebral artery occlusion and vertebral artery dissection, leading to severe neurological deficits after delayed treatment. The commentary highlights the importance of thorough neurological investigation of patients presenting with dizziness and other simultaneous neurological symptoms, the challenges of diagnosing transient ischemic attack (TIA) – particularly in a young, healthy adult, and the limitations of non-contrast brain CT for identifying TIA or early ischemic strokes in patients presenting with dizziness.

Finding SAMHSA Training and Technical Assistance for Mental Health and Substance Use

https://www.samhsa.gov/resource-search/tta?utm_source=SAMHSA&utm_campaign=446ed53f58-EMAIL_CAMPAIGN_2024_12_17_10_09&utm_medium=email&utm_term=0_-446ed53f58-167840245 SAMHSA-funded training and technical assistance centers offer free support to people working in the field on topics across the behavioral health spectrum. This includes assistance for states, tribes, non-profits, communities, health care professionals, and behavioral health specialties including licensed clinicians and peer support specialists. Training and technical assistance serves: National audiences through webinars, online learning modules, and written resources Specific groups through topic-based virtual learning collaboratives, communities of practice, or short-term training Communities, states, tribes, and systems through intensive individualized technical assistance Some programs may offer continuing education credits. You can now search for centers that meet your needs on SAMHSA’s new training and technical assistance webpage at samhsa.gov/technical-assistance.

Making Healthcare Safer IV: Patient Monitoring Systems To Prevent Failure To Rescue

Making Healthcare Safer IV: Patient Monitoring Systems To Prevent Failure To Rescue: Objective: To review the evidence published after the previous Making Healthcare Safer (MHS) report on the effectiveness of implementing patient monitoring systems that scan patient data for signs of clinical deterioration to alert a clinician of a potential adverse condition.

2025 Annual Research Meeting Valuable Evidence. Vibrant Community. Vital Conversations.

https://academyhealth.org/ARM Nominations are now being accepted for the HCUP Award for Outstanding (Clinical) Research and the HCUP Award for Outstanding (Policy) Research, co-sponsored by AHRQ and AcademyHealth. The awards recognize research published in peer-reviewed journals that used the HCUP databases to explore and address healthcare topics. The publications must have occurred between July 1, 2022, and June 30, 2024. Work honored demonstrates how HCUP has contributed to the healthcare services field. Authors may self-nominate or be nominated by another individual. One nomination per author/individual/research group per category will be accepted. For those nominating an individual, please notify the author. Awards will be presented during an HCUP session at the 2025 AcademyHealth Annual Research Meeting (ARM), which will be held June 7-10, 2025 in Minneapolis, MN.

Registration Is Open for Our January 21 Webinar: “Engineering Safety into Practice through Implementation of the 2025 SAFER Guides”

https://cma.ahrq.gov/cma/welcome.jsp?code=naajan2025 As the modern healthcare delivery system continues to evolve, the safe and effective design, development, implementation, and use of electronic health records (EHRs) as the primary means of patient data collection, storage, retrieval, and communication becomes more apparent. The safety of our patients, workforce, and health care system requires a shared commitment and responsibility to evidence-based practices known to help the health IT community improve the safety and safe use of information systems vital to health care delivery. The Safety Assurance Factors for EHR Resilience (SAFER) guides are designed to help healthcare organizations of all sizes from individual practices to large hospital systems meet that responsibility by conducting proactive self-assessments to evaluate the safety and effectiveness of their electronic health record (EHR) implementations. The 2025 SAFER guides have been updated and streamlined to focus on the highest risk, most commonly occurring issues that can be addressed through technology or practice changes to build system resilience. Join us on January 21, 12:00-1:00 PM ET, for a session on engineering safety with Dean Sittig, PhD and Hardeep Singh, MD, MPH, the authors of the SAFER Guides, as they discuss the development of this latest version and the use of the guides for self-assessments.

SAMHSA Commits to Sustaining and Accelerating HIV Progress

https://www.samhsa.gov/blog/samhsa-commits-sustaining-accelerating-hiv-progress?utm_source=SAMHSA&utm_campaign=77e63883f4-EMAIL_CAMPAIGN_2024_12_18_05_15&utm_medium=email&utm_term=0_-77e63883f4-167840245 SAMHSA Commits to Sustaining and Accelerating HIV Progress By: Kristin Roha, M.S., M.P.H., Public Health Advisor for HIV, Center for Substance Abuse Treatment World AIDS Day, established in 1988 and observed annually on December 1, is a day to commemorate the 42 million people globally who have died from AIDS-related illnesses since the start of the epidemic, and honor the more than 39 million people including 1.2 million Americans, living with HIV around the world. This year’s World AIDS Day theme, Collective Action: Sustain and Accelerate HIV Progress, serves as an important reminder that we must remain steadfast in our commitment to prevent new HIV infections and provide essential services to all people living with HIV. However, despite the advancements we have made around the world and in the United States, our progress has been uneven, and challenges remain. In too many communities, limited public awareness, lack of access, and sparse partner engagement continue to create barriers to comprehensive HIV prevention and treatment. https://www.hiv.gov/blog/world-aids-day-2024-collective-action-sustain-and-accelerate-hiv-progress?utm_source=SAMHSA&utm_campaign=77e63883f4-EMAIL_CAMPAIGN_2024_12_18_05_15&utm_medium=email&utm_term=0_-77e63883f4-167840245