Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts
CMS will start auditing Medicare Advantage plans as part of a significant increase in enforcement measures aimed at ensuring compliance and accountability within the program. This move is expected to enhance oversight and improve the quality of care provided to beneficiaries.
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Medicare plots ambitious tech agenda guided by former Palantir, Main Street Health executives
Medicare is planning a significant technology modernization push, aiming to enhance patient care through AI tools and improved data sharing, while seeking input from stakeholders on their experiences and needs.
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Cantor Fitzgerald flags CMS audit strategy as healthcare sentiment risk
Cantor Fitzgerald highlights concerns regarding the CMS audit strategy, suggesting it poses a risk to healthcare sentiment. The report indicates that the audit approach may impact the financial stability of healthcare providers. The implications could affect both patient care and provider operations.
#Hospital, #Provider, #Patient
CMS outlines tweaks to ACO REACH for 2026 performance year
The Centers for Medicare and Medicaid Services (CMS) has announced modifications to the ACO REACH program for the 2026 performance year, aiming to enhance its effectiveness and adapt to evolving healthcare needs. These changes are part of CMS’s ongoing efforts to improve value-based care models.
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CMMI’s New Strategic Direction: What to Know
The article discusses the new strategic direction of the Center for Medicare and Medicaid Innovation (CMMI), focusing on its approach to value-based care and innovation in healthcare delivery. It outlines key initiatives aimed at improving patient outcomes and reducing costs. Stakeholders are encouraged to stay informed about these changes as they could significantly impact healthcare practices.
#Provider, #Hospital, #Patient
Food and Drug Administration (FDA)
Opinion: FDA’s New Vaccine Policy: How Flawed Reasoning Threatens Public Health in the Name of Scientific Rigor
The policy, which creates a bifurcated system for testing vaccines in supposedly low- and high-risk populations, serves neither science nor public health. It is an inconsistent framework masquerading as a principled compromise, and it will leave the nation under-vaccinated.
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Opinion: Former FDA commissioner: ‘Cost-cutting’ may undo one of Trump’s best drug pricing achievements
Scott Gottlieb, former FDA commissioner, argues that cost-cutting measures could undermine the FDA’s previous successes in promoting affordable generic drugs during the Trump administration. He highlights the complexities of modern drugs that hinder generic competition and reflects on the FDA’s initiatives to facilitate the approval of generics.
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Health and Human Services (HHS)
CDC keeps publishing papers after firing scientists behind the research
The CDC continues to publish research papers despite the dismissal of the scientists who contributed to them, raising concerns about the integrity and future capabilities of the agency. Critics argue that this situation reflects a loss of valuable expertise and undermines trust in public health communications.
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CDC Ends COVID Vaccine Recs for Healthy Kids, Pregnant Women
The CDC has officially removed its recommendation for healthy children and pregnant women to receive routine COVID-19 vaccinations. This decision, announced by HHS Secretary Robert F. Kennedy Jr., has sparked significant debate among health professionals regarding its implications for public health.
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RFK Jr. set to face the senator who grilled him
Senator Bill Cassidy is set to question Robert F. Kennedy Jr. at an upcoming hearing, following Kennedy’s previous commitments to vaccine protection. This interaction highlights ongoing tensions regarding health policy and vaccine advocacy.
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RFK Jr. calls for global health cooperation outside the World Health Organization
Robert F. Kennedy Jr. advocates for international health collaboration independent of the World Health Organization, rejecting a recent pandemic agreement. His stance reflects a broader debate on global health governance and cooperation.
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RFK Jr. says food and pharma are poisoning Americans. His big report says a fix is coming.
Kennedy’s Make America Healthy Again Commission is set to unveil a strategy aimed at addressing chronic diseases, claiming that the food and pharmaceutical industries contribute to health issues in the U.S. This report is anticipated to influence public health discussions.
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RFK Jr.’s report had a surprise target: your doctor
Kennedy’s commission suggests that physicians often misprescribe treatments for chronic diseases, indicating a need for a reevaluation of medical practices. This assertion could lead to significant changes in how healthcare providers approach patient care.
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‘MAHA’ Report On Chronic Disease Will Cause Major Shift In Healthcare, FDA Chief Predicts
The FDA chief predicts that the upcoming ‘MAHA’ report on chronic diseases will lead to significant changes in healthcare policies and practices. This report aims to address the growing burden of chronic conditions and improve overall health outcomes.
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White House Health Report Included Fake Citations
A report by the Make America Healthy Again Commission has been criticized for referencing non-existent scientific papers, raising concerns about the credibility of its findings.
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‘Corrupt’ medical journals have to change, RFK Jr. says, or the NIH will publish in-house
Kennedy has threatened to restrict NIH scientists from publishing in prominent medical journals, claiming they are compromised by pharmaceutical interests. This move could impact the dissemination of scientific research and academic freedom.
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HHS, CMS question hospitals on policies, finances related to gender-affirming care
HHS and CMS are inquiring about hospitals’ policies and financial practices concerning gender-affirming care, indicating a focus on ensuring compliance and appropriate resource allocation in this area. On Wednesday afternoon, Health and Human Services Secretary Robert F. Kennedy Jr. penned a letter to healthcare providers, risk managers and state medical boards referring them to a recent evidence review published by the department.
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Hill Happenings
First time we were hearing of them’: The GOP megabill is packed with surprises for some Republicans
Senior Republicans on the House Energy and Commerce Committee expressed surprise at the inclusion of Medicaid provisions in a significant GOP bill, indicating a lack of communication within the party regarding healthcare strategies. This revelation raises questions about party alignment and legislative transparency.
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President Trump’s spending bill: A tipping point for hospitals and FQHCs
The article discusses the implications of President Trump’s spending bill, which proposes significant cuts to Medicaid and could adversely affect hospitals and federally qualified health centers (FQHCs). The author argues that these changes threaten access to care for vulnerable populations and could lead to increased healthcare costs in the long run.
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Top Democrats in Congress decry White House ‘lack of transparency’ in spending plans
Democratic lawmakers are demanding clarity from the Trump administration regarding its spending plans for government operations, following concerns about incomplete submissions to Congress. They emphasize the importance of transparency for effective oversight and appropriations for the upcoming fiscal year.
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It’s not repeal, but Congress is about to slash ‘Obamacare’
Congress is poised to roll back aspects of the Affordable Care Act, including cuts to Medicaid expansion and stricter marketplace coverage, as part of a broader healthcare reform agenda.
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Providers urge Congress: Fix Medicare payment model bonuses
Healthcare providers are calling on Congress to restore Medicare bonus payments, which they argue are essential for maintaining high-quality care amidst ongoing payment model challenges.
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Notable Notes
Court orders government to restore articles on LGBTQ health
A court ruling mandates the restoration of articles related to LGBTQ health that were previously removed from government websites. This decision underscores the importance of accessible health information for all communities.
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NIH cuts tracked by researchers in Grant Watch database
Researchers have developed a database to track NIH grant terminations, highlighting the impact of funding cuts on scientific research. This initiative aims to rally the scientific community to address the challenges posed by reduced funding.
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Young scientists say they may abandon research as their career options shrink amid Trump cuts
Young researchers are expressing concerns about the diminishing career opportunities in science due to funding cuts, which may lead to a loss of talent in the field. This trend highlights the challenges facing the next generation of scientists.
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Opinion: Race doesn’t affect the onset or progression of disease — racial bias does
Race has no biological basis and no effect on the onset or progression of disease. Being Black doesn’t put you at a greater risk for sickle cell disease; having ancestry from a place with high rates of malaria does. You can have white skin and still have sickle cell disease, especially if you have Mediterranean ancestry. When race is used as a crude proxy, we miss the real risk — we underdiagnose and misdiagnose. We increase medical costs and preventable diseases.
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Opinion: Why It’s So Hard to Cut Healthcare Costs
When stakeholders benefit from the status quo they resist change
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How Trump’s Regulatory Rollbacks Are Increasing Costs on Americans
Recent regulatory rollbacks by the Trump administration are claimed to save money for Americans, but data suggests these changes may actually increase costs instead.
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Most HIV Patients Trust Their Providers But Don’t Always Feel Heard, Survey Says
Trust and communication between HIV patients and their providers are essential parts of successful treatment; however, patients sometimes feel ignored at appointments, and some are lacking important information about managing their disease, according to the first set of results from ViiV Healthcare’s Positive Perspectives 3 survey, released today. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/may/positive-perspectives-survey/
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Wait Times for Physician Appointments Surged in Recent Years
A recent survey indicates that average wait times for physician appointments have significantly increased across various medical specialties in major U.S. metropolitan areas. This trend raises concerns about access to timely healthcare for patients.
#Provider, #Patient
Docs say ‘broken promises’ could slow private equity-linked deals
Doctors are facing bureaucratic challenges with private equity-backed employers, which may hinder patient care and revenue generation. This situation reflects ongoing tensions between healthcare providers and financial entities in the medical field.
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The state of physician practices in 5 charts
An analysis by the American Medical Association reveals a decline in the percentage of physicians working in private practice, marking the lowest level since the survey began in 2012. This trend indicates a shift in the healthcare landscape towards employment models.
#Provider, #Patient
Boston Scientific pulls heart device from market
Boston Scientific has ceased global sales and FDA approval efforts for its Acurate neo2 and Acurate Prime aortic valve systems due to high costs and poor performance in studies, where over 20% of the devices failed to expand properly after implantation.
#Device, #Patient
A Peek at the Pipeline of Transcatheter Tricuspid Valve Replacement Systems
The race to develop transcatheter systems for tricuspid regurgitation (TR) continues, and early-stage report cards are in for several investigational devices. Progress with transcatheter tricuspid valve replacement (TTVR) candidate devices Topaz, LuX-Valve Plus, VDyne, and Trisol for severe to torrential TR was shared at the EuroPCRopens in a new tab or window meeting in Paris, continuing the notable flurry of transcatheter innovationopens in a new tab or window in this space.
#Device,#Patient, #Provider
FDA approves self-expanding Tendyne TMVR device from Abbott
Abbott has received U.S. Food and Drug Administration (FDA) approval for its Tendyne transcatheter mitral valve replacement (TMVR) device to treat patients with severe mitral annular calcification (MAC). The self-expanding valve, which gained CE mark approval back in 2020, is available in multiple sizes and can be fully retrieved and repositioned as necessary during implantation.
#Device, #Patient, #Provider
Cardiologist shares positive first-in-human data on TriCares TTVR device
A cardiologist reported promising results from the first human trials of the Topaz TTVR device, which effectively eliminated tricuspid regurgitation without the need for a permanent pacemaker in the initial group of patients. This advancement could represent a significant step forward in cardiac care.
#Provider, #Patient, #Hospital
Meril TAVR valves linked to 1-year outcomes similar to industry-leading devices from Medtronic, Edwards
The Meril Life Sciences’ Myval TAVR valves have shown one-year outcomes comparable to those of leading devices from Medtronic and Edwards, according to recent clinical trial data. However, the company is still awaiting FDA approval for its product.
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