Weekly Spotlight
Last Friday RFK Jr. surprised the health policy world by directing the Department of Health and Human Services to terminate notice and public comment process in rulemaking in “matters relating to agency management or personnel or to public property, loans, grants, benefits or contracts,” deeming it ‘extra-statutory’ and unnecessary.” It remains unclear what rules will be subject to this new decree. With annual payment proposed rules already sitting at OMB for review, the answers are sure to come soon.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
STAT+: Medicare and Medicaid agency faces compromised functions and disruption from Trump’s firings
The Centers for Medicare and Medicaid Services is grappling with employee firings and low morale due to recent cuts from the Trump administration, threatening the agency’s ability to effectively manage crucial healthcare programs for millions of Americans.
#All
Food and Drug Administration (FDA)
How Early FDA Engagement Can Accelerate Medical Device Approval & Reduce Market Delays
At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will show why it is important to engage with FDA as early as possible.
#All
Health and Human Services (HHS)
Renowned Geneticist Francis Collins, MD, PhD, Retires from NIH
Renowned geneticist Francis Collins has retired from his position as director of the NIH, amidst significant budget cuts and layoffs affecting the agency.
#All
NIH has paused patenting of discoveries, slowing their use in developing treatments
The NIH has halted patent applications and licensing, significantly hindering the agency’s ability to advance its research discoveries into drug and vaccine development amidst stringent restrictions imposed by the Trump administration.
In addition, NIH is abruptly terminating millions of dollars in research awards to scientists in Massachusetts and around the country, citing the Trump administration’s new restrictions on funding anything related to diversity, equity, and inclusion, transgender issues, or research that could potentially benefit universities in China.
The sweeping actions would appear to violate court rulings from federal judges in Rhode Island and Washington, D.C., that block the Trump administration from freezing or ending billions of dollars in government spending.
#All
Healthcare groups push back against J&J rebate model in amicus brief
Four healthcare groups have filed an amicus brief in opposition to Johnson & Johnson’s 340B rebate model, arguing the policy undermines federal law and threatens safety-net hospitals.
#Drug, #Hospital
Hill Happenings
Medicaid cuts must occur to meet GOP budget goals: CBO
The only way to reach a savings goal of $880 billion in healthcare spending over the next decade is through cuts to Medicaid or CHIP, according to a new report from the Congressional Budget Office. As Congress considers changes to the Medicaid program as part of budget conversations, the latest KFF Health Tracking Poll finds that fewer than one in five adults (17%) want to see Medicaid funding decreased, and most think funding should either increase (42%) or be kept about the same (40%).
Democrats are seizing the opportunity presented by proposed Medicaid cuts in the Republican budget to rally public opposition and potentially replicate the electoral success they achieved in 2018, when they focused on health care issues.
#All
Trump’s FDA chief nominee Makary promises role for vaccine expert committee – Reuters.com
Trump’s nominee for FDA chief, Dr. Marty Makary, has pledged to establish a vaccine expert committee to guide the agency’s decisions on vaccine approvals and policies and other key takeaways from the confirmation hearing.
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Senators Challenge Trump’s NIH Pick on Vaccines, Grant Freezes
Senators scrutinized Jay Bhattacharya, President Trump’s nominee for the NIH, regarding his stance on vaccines and the limitations on agency funding amid an ongoing pandemic.
#All
A Skeptical G.O.P. Senator Makes His Peace With Kennedy
Senator Bill Cassidy, initially skeptical of Robert F. Kennedy Jr.’s vaccine stance as President Trump’s health secretary, has reconciled his views following a measles outbreak in Texas, acknowledging that Kennedy’s recent statements on vaccination encourage parents to consult their doctors, ultimately advocating for vaccination despite tensions within the Republican party regarding public health measures.
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Congressional Spending Negotiations in 2025: Scenario Planning
Lawmakers have until midnight on March 14, 2025, to avert a government shutdown by reaching an agreement on federal funding. Central to the negotiations are discretionary spending caps Congress set nearly two years ago that include various incentives to proactively pass appropriations bills by April 30, and potential across-the-board spending cuts (sequestration) if a stopgap continuing resolution (CR) is in place for some or all spending categories after that date.
Below, the Bipartisan Policy Center outlines the ways that fiscal year 2025 funding negotiations could play out in the coming weeks.
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Notable Notes
USAID Official Placed on Admin Leave after a Serries of Scathing Memos
The top global health official at the U.S. Agency for International Development was placed on administrative leave on Sunday after signing off on a series of memos detailing how America’s global health programs have been paralyzed since late January, putting millions of people around the world at risk of disease and death
Documentation of challenges and impediments to implementing the lifesaving
humanitarian assistance waiver for the pause on foreign assistance
Documentation of Bureau for Global Health Workforce Reduction
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Opinion: STAT+: Volatile is the new normal for the biotech workforce
The biotech workforce is experiencing unprecedented volatility, marked by rapid company failures and layoffs, as the high costs and complexities of drug development push startups to either quickly meet milestones for acquisition or face collapse.
#Device, #Drug
Cardiologists make history, complete world’s first robotic transcatheter mitral valve replacements
One of the cardiologists involved in the procedures said they represent “a significant leap forward in structural heart intervention.”
#Device, #Hospital, #Provider, #Patient
FDA approves design updates for Perceval Plus surgical aortic valve
The valve’s sutureless, collapsible frame was built to simplify implantation and help patients recover faster following surgery. This updated version features laser-cut details and was shaped using a zero-pressure fixation process.
#Device, #Hospital, #Provider, #Patient
Cardiologists are first in world to use new TAVR catheter from Boston Scientific
The new Self-Centering Guide Catheter was designed to help care teams with the retrograde crossing of the aortic valve during TAVR. Researchers evaluated the safety and effectiveness of the catheter, sharing their experience in JACC: Cardiovascular Interventions.
#Device, #Hospital, #Provider, #Patient
TAVR vs. SAVR: Real-world data highlight advantages of both techniques
The biggest differences, researchers noted, were found in the long-term outcomes of low- and intermediate-risk patients.
#Device, #Hospital, #Provider, #Patient
Cardiologists treat first commercial patients with FDA-cleared valve-in-valve TAVR device
Pi-Cardia, an Israeli medtech company, announced that multiple heart teams throughout the United States have now used its ShortCut leaflet modification device to perform successful valve-in-valve transcatheter aortic valve replacement (TAVR) procedures.
#Device, #Hospital, #Provider, #Patient
Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines
U.S. medical societies have collaborated on new acute coronary syndrome (ACS) guidelines focused on the comprehensive management of patients presenting with unstable angina, ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). The American College of Cardiology (ACC) and American Heart Association published the new guidelines with assistance from the American College of Emergency Physicians, National Association of EMS Physicians and Society for Cardiovascular Angiography & Interventions. The recommendations are available in full in both JACC and Circulation.[1, 2]
#Device, #Hospital, #Provider,#Patient
Surgeons make history, perform world’s first living mitral valve replacement
Surgeons have achieved a groundbreaking milestone by performing the world’s first living mitral valve replacement, which played a crucial role in saving the lives of three young girls.
#Device,#Hospital,#Provider,#Patient
Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’
Several major cardiology organizations are expressing deep disappointment following the denial of their proposal for an American Board of Cardiovascular Medicine, but they remain committed to pursuing the initiative.
#Provider
The Not-So-Hidden ROI of Patient Experience Initiatives
Enhancing patient experience is a crucial factor for financial and operational success in healthcare, as higher patient satisfaction leads to better clinical outcomes, improved clinician engagement, and significant financial returns for hospitals
#Hospital, #Patient, #Payer, #Provider
Pharmacy residents sue 11 hospitals, ASHP over alleged wage fixing
A proposed class-action lawsuit accuses 11 hospitals, the American Society of Health-System Pharmacists and a matching service of attempting to suppress wages for pharmacy residents.
#Provider
