Policy Update – June 30, 2025

Introduction
This Week: The Big Beautiful Bill, More Vaccine Drama… and a July 4th Recess

Weekly Spotlight

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Trump’s Big Beautiful Bill Nears the Finish Line… Maybe

The Senate is currently grappling the “Big, Beautiful Bill,” which aims to implement significant changes to healthcare, particularly Medicaid, and tax policies. This report synthesizes the latest developments regarding the bill, highlighting the challenges posed by the Senate parliamentarian’s rulings, internal GOP divisions, and the implications for healthcare funding and tax cuts.

Parliamentarian Rulings and Compliance Issues

  • The Senate parliamentarian has ruled that several provisions of the bill violate the Byrd Rule, which governs budget reconciliation bills. Key Medicaid provisions aimed at increasing funding for Alaska and Hawaii were disallowed, along with attempts to expand Medicare drug-price negotiation exemptions.
  • Provisions to block Biden-era regulations facilitating Medicaid enrollment for seniors and individuals with disabilities were also struck down.

Internal GOP Negotiations

  • Senate Republicans are facing significant pressure to ensure the bill passes by a self-imposed July 4 deadline. Despite initial opposition from some GOP senators, a recent vote to advance the bill suggests a fragile consensus is forming, albeit with ongoing negotiations.
  • GOP leaders are modifying the bill to address concerns from holdouts, particularly regarding Medicaid funding cuts that could impact rural hospitals. A proposed $25 billion fund for rural hospitals was introduced to alleviate fears of closures due to Medicaid cuts.

Tax Provisions and Fiscal Concerns

  • The Senate’s tax provisions are under scrutiny, with a new accounting method being utilized to present a lower cost for tax cuts. This method has raised concerns among critics who argue it obscures the true financial implications of the bill.
  • House Republicans are wary of the Senate’s approach, particularly regarding its impact on the national debt and the need for corresponding spending cuts to offset tax reductions.

Public and Political Reactions

  • The bill has faced backlash from healthcare advocates and some Republican senators who fear it could lead to millions losing Medicaid coverage. Notably, Dr. Mehmet Oz has been deployed by the White House to advocate for the bill, despite concerns from within the GOP.
  • Public opinion appears to be largely against the bill, with many Americans unaware of its contents, prompting Democrats to push for a thorough reading of the legislation.

The success of the bill is likely to hinge on provisions related to Medicaid, as moderate Republicans express concerns about reduced federal support, especially how this might affect rural hospitals that rely heavily on Medicaid patient populations. Senator Rick Scott of Florida is expected to propose an amendment that would drastically reduce the federal matching rate for Medicaid under the Affordable Care Act (ACA) expansion from 90% to approximately 50% starting in 2031, potentially cutting $313 billion from federal Medicaid spending. The Senate version of the bill aims to extend Medicaid work requirements to parents with children aged 15 and older, while allowing the Health and Human Services (HHS) Secretary to grant exemptions to states making progress on these requirements until 2028.

The Senate has advanced the bill by a narrow 51-49 vote and is currently engaged in a series of amendments, often referred to as “vote-a-rama.” A self-imposed deadline of July 4 has been set for finalizing the agreement between the Senate and the House before sending it to President Trump for signing.

The Senate’s efforts to pass the revised domestic policy bill are fraught with challenges, including compliance with budget rules, internal party divisions, and public skepticism. The ongoing negotiations reflect deep concerns about the potential impacts on Medicaid funding and tax policies, with significant implications for healthcare access and fiscal responsibility. As the deadline approaches, the Senate must navigate these complexities to achieve a final legislative product that can garner enough support from both chambers.

Articles Consulted:

  1. Senate rulekeeper deals blows to revised ‘Big, beautiful bill’ – POLITICO – TOP Stories
  2. Senate Republicans put megabill on track for likely Monday passage – POLITICO – TOP Stories
  3. STAT+: Senate GOP tweaks health care measures in tax bill to win holdouts, please parliamentarian – Stat
  4. Fresh megabill text overnight: what’s in and what’s out – POLITICO – TOP Stories
  5. STAT+: GOP tax bill faces major setback as Senate parliamentarian strikes down key Medicaid measures – Stat
  6. Republicans Prepare to Open ‘Pandora’s Box’ of Budget Gimmicks – The New York Times
  7. White House sends Dr. Oz to calm Senate nerves – POLITICO – TOP Stories
  8. Former governors warn that Medicaid cuts would have dire consequences – Stat
  9. The megabill’s math isn’t adding up for Senate Republicans – POLITICO – TOP Stories
  10. Trump’s megabill gets a late makeover in the Senate – POLITICO – TOP Stories
  11. Most fed-targeting provisions in Senate reconciliation bill don’t pass Byrd muster – Government Executive – All Content
  12. Opinion: The Senate’s version of Trump’s tax-cut bill threatens safety-net hospitals like ours – Stat
  13. STAT+: Senate Republicans discuss new way to cut Medicaid in Trump’s tax bill – Stat
  14. Senators pitch rural hospital fund in budget bill – Becker’s Hospital Review
  15. Senate parliamentarian greenlights state AI law freeze in GOP megabill – POLITICO – TOP Stories
  16. Senate GOP slashes megabill’s tax costs with new accounting method – POLITICO – TOP Stories
  17. Senate GOP’s plan to push food aid costs onto states axed from megabill – POLITICO – TOP Stories
  18. Tracking the Medicaid Provisions in the 2025 Reconciliation Bill – KFF – “healthcare and CMS” – Google News
  19. Medicaid Cuts, Matching Rate Sticking Points in Reconciliation Bill – Managed Healthcare Executive

More Vaccine Drama Unfolds

The recent developments in U.S. vaccine policy have sparked significant controversy, particularly following the actions of Health and Human Services Secretary Robert F. Kennedy Jr. His decision to completely overhaul the Advisory Committee on Immunization Practices (ACIP) has raised concerns about the integrity of vaccine recommendations and public health. This report synthesizes various articles discussing the implications of these changes, the reactions from medical professionals, and the broader context of the ongoing vaccine discourse.

New Vaccine Policy Era

  • Kennedy’s dismissal of all previous ACIP members and the appointment of new members with ties to anti-vaccine sentiments has been characterized as a move to reshape vaccine policy in the U.S. This shift has been met with skepticism from public health experts, who argue that the new committee lacks credibility and trustworthiness.
  • Dorit Reiss, a vaccine law expert, has suggested that the integrity of the ACIP may now be compromised, calling for its potential disbandment or legislative reforms to restore public trust.

Impact on Public Health

  • The American Medical Association (AMA) and other medical associations are voicing strong opposition to Kennedy’s actions, emphasizing the critical role of ACIP in establishing evidence-based vaccine recommendations that protect public health.
  • Critics argue that undermining the committee could lead to increased vaccine hesitancy and a resurgence of preventable diseases, jeopardizing the health of children and communities.

Political and Financial Implications

  • The restructuring of ACIP coincides with a broader political landscape where vaccine funding and support for organizations like Gavi are being reconsidered. Kennedy’s announcement to cut U.S. funding to Gavi, citing a lack of scientific adherence, marks a significant shift in U.S. global health policy.
  • The National Institutes of Health (NIH) is also facing financial challenges, with reports indicating a growing funding gap that may impact research and public health initiatives.

Responses from Medical Professionals

  • Physicians and public health advocates are increasingly concerned about the implications of Kennedy’s policies. An opinion piece highlights the potential dangers of undermining vaccine experts, arguing that it could lead to more misinformation and health crises.
  • The discontent within the medical community is palpable, as many feel that the recent changes threaten decades of progress in vaccine science and public health.

The ongoing transformation of vaccine policy under Kennedy’s leadership represents a pivotal moment in U.S. public health. The dismissal of trusted experts from the ACIP, coupled with controversial funding decisions, raises serious questions about the future of vaccination practices and public trust in health authorities. As the debate continues, the need for a balanced, evidence-based approach to vaccines remains critical to safeguarding public health.

Articles Consulted:

  1. A new era of vaccine policy has arrived – Stat
  2. Major association of physicians presents itself as a go-to alternative vs. the government on vaccine expertise – Health Exec
  3. Inside CDC’s All-Hands; ‘Lies’ About Measles; The Two Weeks That Doomed USAID – MedPageToday.com – medical news for physicians
  4. RFK Jr. Accuses Gavi, Global Vaccine Agency, of Ignoring Science – The New York Times
  5. CDC vaccine advisory committee to review long-approved immunizations – Stat
  6. Trump’s pick to run CDC ratifies importance of vaccines as RFK Jr. moves to limit access – Stat
  7. Kennedy’s vaccine panel to review childhood immunization schedule – POLITICO – Health Care
  8. STAT+: Trump’s pick to run the CDC walks a fine line on RFK Jr. at Senate hearing – Stat
  9. Kennedy Announces U.S. Will Cut Off Vaccine Funding To Gavi – InsideHealthPolicy Daily News
  10. RFK Jr.’s Vaccine Panel to Study Childhood Immunization Schedule – MedPageToday.com – medical news for physicians
  11. RFJ Jr. says US won’t donate to global vaccine effort – POLITICO – Health Care
  12. RFK Jr.’s Handpicked Vaccine Advisers Are Set to Meet for the First Time – The New York Times
  13. Physician Lawmaker Confronts RFK Jr. About ACIP Firings: ‘You Lied’ – MedPageToday.com – medical news for physicians
  14. Cassidy, in Break With RFK Jr., Calls for Vaccine Meeting Delay – The New York Times
  15. STAT+: Insurance coverage of vaccines at risk in RFK Jr.’s reshuffling of CDC’s vaccine advisers – Stat
  16. STAT+: Radical transparency at the FDA, and a pivotal moment for vaccines – Stat
  17. Cassidy calls to delay meeting of CDC’s vaccine panel in challenge to RFK Jr. – Stat
  18. Cassidy criticizes RFK Jr.’s vaccine advisers – POLITICO – Health Care
  19. AMA resolution opposes RFK Jr.’s dismantling of vaccine panel – Section Page News – Modern Healthcare
  20. Health secretary RFK Jr. abruptly fires CDC vaccine advisory panel – Stat
  21. RFK Jr. Removes All C.D.C. Vaccine Panel Experts – The New York Times
  22. RFK Jr. Ousts All of CDC’s Vaccine Advisors – MedPageToday.com – medical news for physicians
  23. RFK Jr. to fire all members of the CDC’s vaccine advisory committee – POLITICO – Health Care
  24. RFK fires entire vaccine committee at CDC – Health Exec
  25. Four CDC committee termination notices and new federal documents – Stat
  26. RFK Jr. fires CDC vaccine advisers – Stat
  27. STAT+: ‘People inside Moderna are afraid’: As anti-vaccine climate intensifies, the company has much to lose – Stat
  28. Opinion: RFK Jr.’s attack on vaccine experts endangers every American  – Stat
  29. Firing of CDC’s vaccine advisers puts spotlight on RFK Jr.’s promises to Cassidy  – Stat
  30. CDC backtracks on layoffs, rehires more than 400 people – POLITICO – Health Care
  31. HHS reverses hundreds of CDC firings – Stat
  32. RFK Jr. names new members of CDC’s vaccine advisory panel – Stat
  33. Hundreds of Laid-Off CDC Employees Are Being Reinstated – MedPageToday.com – medical news for physicians
  34. RFK Jr. Announces Eight New Members of CDC Vaccine Advisory Panel – The New York Times
  35. Opinion: By remaking CDC’s vaccine advisory panel, RFK Jr. is destroying public trust – Stat
  36. RFK Jr. names new vaccine advisers – Stat

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

ACA Exchange Changes

CMS is implementingsignificant changes concerning the Affordable Care Act (ACA) and health insurance exchanges. These changes aim to tighten enrollment rules, enhance verification processes, and combat fraudulent enrollments, reflecting the administration’s ongoing efforts to manage ACA-related spending and improve program integrity.

Tightening Access to ACA Programs

  • The Trump administration’s new plan includes stricter income verification for subsidies and limits on open enrollment periods. This approach is designed to reduce ACA-related expenditures and eliminate access for some young immigrants.

Fraud Prevention Measures

  • CMS has introduced rules targeting fraudulent health insurance enrollments within ACA exchanges. These measures are part of a broader initiative to ensure that the enrollment process is secure and that subsidies are properly allocated.

Integrity Provisions Finalized

  • On June 20, CMS temporarily finalized several provisions aimed at enhancing the integrity of health exchange programs through 2026. These include new verification requirements and modifications to the auto re-enrollment process, paving the way for potential Senate codification of these policies.

The recent actions by CMS signify a robust effort to streamline ACA processes and eliminate fraudulent activities within health insurance enrollments. By enforcing stricter verification protocols and adjusting enrollment periods, the administration aims to enhance the integrity and sustainability of the ACA. These changes are anticipated to have a substantial impact on how individuals access health insurance through the exchanges, potentially limiting coverage for certain demographics.

Articles Consulted:

  1. CMS Tightens Reins on Obamacare – Medpage Today
  2. CMS targets fraudulent health insurance enrollments in new rule for ACA exchanges – Medical Economics
  3. CMS tightens exchange enrollment rules – Modern Healthcare
  4. CMS Final Rule

CMMI model to add prior authorization to some Medicare services – Modern Healthcare

The Center for Medicare and Medicaid Innovation (CMMI) is set to implement a model that will introduce prior authorization requirements for certain Medicare services, marking a significant policy shift. This change aims to enhance oversight and potentially reduce unnecessary healthcare spending.

#Payer

Oz hints at impending CMS rule to force drug price transparency

Dr. Mehmet Oz has suggested that a new rule from the Centers for Medicare & Medicaid Services (CMS) is on the horizon, aimed at enhancing drug price transparency. This initiative is part of broader efforts to ensure fair pricing in the pharmaceutical industry.

#Payer, #Drug

Food and Drug Administration (FDA)

FDA Launces Expedited Drug Review Process

On June 17, the U.S. Food and Drug Administration (FDA) announced the launch of the Commissioner’s National Priority Voucher (CNPV) program aimed at expediting the drug review process for pharmaceutical companies. This initiative seeks to align drug development with national health priorities, thereby enhancing public health outcomes and increasing domestic drug manufacturing.

The CNPV program offers drug developers an opportunity to significantly shorten the FDA review timeline from the standard 10-12 months to just 1-2 months post-final application submission. The program employs a multidisciplinary team approach, where clinical data is reviewed by a group of experts in a “tumor board-style” meeting, allowing for a more efficient decision-making process. FDA Commissioner Marty Makary emphasized that this model draws from collaborative medical practices to ensure timely and effective evaluations.

Key national health priorities identified by the FDA include:

  • Addressing health crises in the U.S.
  • Delivering innovative cures
  • Meeting unmet public health needs
  • Enhancing domestic drug production for national security

To qualify for the CNPV, companies must submit the chemistry, manufacturing, and controls (CMC) portion of their application and draft labeling at least 60 days before the final submission. Continuous communication with the FDA during the review process is also required. The FDA retains the right to extend review periods if the submitted data is deemed insufficient or if the review complexity increases.

The program reflects the FDA’s commitment to modernizing regulatory frameworks and improving efficiency in drug approvals while maintaining rigorous safety and efficacy standards. It is part of a broader strategy by the current administration to incentivize domestic drug manufacturing and reduce drug prices through various means, including potential tariffs on companies that do not comply with these priorities.

The FDA’s new CNPV program represents a significant shift in how drug approvals will be handled, focusing on speed and collaboration to meet pressing health needs. By aligning drug development with national priorities, the FDA aims to foster innovation and enhance the availability of effective treatments for the American public. This initiative not only promises to expedite the drug approval process but also reinforces the importance of domestic manufacturing in ensuring national health security.

Articles Consulted:

  1. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests – fda.gov
  2. STAT+: FDA announces a new priority review program in bid to further administration goals – Stat
  3. New FDA Chief Wants to Fast-Track Some Drugs, Use More AI – WSJ
  4. US FDA to shorten review time for drug developers under new voucher program – Reuters
  5. FDA to Offer Faster Drug Reviews to Companies Promoting ‘National Priorities’ – MedPageToday.com – medical news for physicians

Radical transparency at the FDA, and a pivotal moment for vaccines

The FDA is experiencing a shift towards greater transparency in its operations, particularly regarding vaccine policies. This moment is seen as critical for public trust and future health initiatives.

#All

FDA’s list of authorized AI-powered medical devices quietly grows

The FDA has authorized over 1,000 medical devices that utilize artificial intelligence (AI) or machine learning, reflecting a significant advancement in AI technology within healthcare. The list encompasses devices across various medical specialties, including radiology and cardiology, and is regularly updated on the FDA’s website. Recently, FDA Commissioner Marty Makary has expedited the introduction of internal AI tools to streamline scientific review processes. This growth highlights the increasing integration of AI in medical technology and its potential to enhance patient care.

#Device

FDA Announces Stakeholder Meetings on the Medical Device User Fee Amendments of Fiscal Years 2028 to 2032 Reauthorization

The FDA is seeking input from public stakeholders regarding their participation in discussions about the reauthorization of the Medical Device User Fee Amendments (MDUFA), which will expire in September 2027. This request aims to ensure consistent stakeholder representation in the ongoing consultations necessary for the development of recommendations for the next MDUFA program. The FDA is required by law to engage with various stakeholders, including patient advocacy groups, to facilitate these discussions.

#Device

Top drug regulator is retiring as FDA departures mount

Jacqueline Corrigan-Curay, the top drug regulator at the FDA, announced her retirement amid a wave of departures from the agency. Her decision follows a challenging period for the FDA, and she expressed gratitude to her staff for their support during her tenure. She told staff that the agency is facing significant changes as she prepares to retire. She noted the need for efficiency and adaptation in light of recent staff reductions and ongoing transitions.

#Drug, #Provider

Health and Human Services (HHS)

Kennedy and Oz Announce Prior Auth Agreement

Recent developments in the healthcare sector have focused on the reform of the prior authorization process, which has long been criticized for causing delays in patient care. Various articles discuss the cautious optimism among healthcare groups regarding new commitments from major insurers to streamline these processes, alongside personal stories highlighting the severe impacts of prior authorization on patients.

Health organizations are cautiously optimistic following an announcement from the Department of Health and Human Services (HHS) regarding voluntary agreements from major insurers aimed at reducing the burdens of prior authorization on healthcare providers and patients who face dire consequences due to the prior authorization process, illustrating the real-life implications of delays in care caused by these administrative hurdles.

Over 50 insurers, including major players like UnitedHealthcare and Aetna, have pledged to simplify the prior authorization process through six new commitments. This initiative is seen as a significant step towards improving patient access to necessary medical care. HHS Secretary Kennedy and CMS Administrator Oz held a press event to announce the industry pledges to reform the prior authorization system. This involvement reflects a broader governmental push to address the inefficiencies in healthcare delivery. However, many have concerns that the recent pledge may have a negligible impact on insurers’ finances, suggesting that while the commitments are promising, their effectiveness in changing the status quo remains to be seen. Further, medical organizations are pushing back against the use of artificial intelligence in the prior authorization process, which they argue could lead to automatic denials and further restrict patient access to care.

The recent announcements regarding prior authorization reform have sparked cautious optimism among healthcare groups, reflecting a potential shift in how insurers manage administrative processes that impact patient care. However, the stark realities faced by patients, as illustrated by individual cases, underscore the urgent need for effective implementation of these reforms. While there is a commitment from insurers and government officials to improve the situation, skepticism about the financial implications and the role of technology in the authorization process suggests that ongoing scrutiny and advocacy will be essential to ensure meaningful change.

Articles Consulted:

  1. Health Groups Cautiously Optimistic on Prior Authorization Announcement – MedPageToday.com – medical news for physicians
  2. Stuck in Prior Authorization, Some Patients Run Out of Options – MedPage Today Oncology/Hematology
  3. CMS administrator touts insurance industry push for prior authorization reform – Healthcare Finance News – “healthcare and CMS” – Google News
  4. Plans Agree to Prior Auth Reform. Physicians and Business Groups Want Measurable Results – Managed Healthcare Executive articles
  5. Major Health Insurers Promise to Improve Prior Authorization – MedPageToday.com – medical news for physicians
  6. HHS Secretary Kennedy, CMS Administrator Oz Secure Industry Pledge to Fix Broken Prior Authorization System – HHS.gov – “healthcare and CMS” – Google News
  7. How Medicare Advantage prior authorization denial rates stack up – modernhealthcare.com
  8. Prior authorizations to ease under new plan from UnitedHealth, Aetna – modernhealthcare.com
  9. STAT+: Health insurers promise to reduce barriers to care under pressure from Trump administration – Stat
  10. ASNC and AMA push back against AI prior authorization denials – Cardiovascular Business – Cardiovascular Business is a leading news website that focuses on the business and economics behind quality clinical care.
  11. Prior authorization pledge seen as negligible to insurer finances – Modern Healthcare
  12. Cohere Health Commends AHIP and CMS for Unified Industry Action on Prior Authorization Reform – Morningstar

Kennedy tells Congress HHS has rehired another 1,250 workers fired by DOGE

Robert F. Kennedy Jr. announced that the Department of Health and Human Services has reinstated 1,250 workers who were previously fired. This move is part of efforts to strengthen the agency’s operational capabilities.

#All

Supreme Court rejects challenge to free preventive care, bolsters RFK Jr.’s power

The Supreme Court upheld a crucial provision of the Affordable Care Act requiring health insurers to cover certain preventive services at no cost. This decision is seen as a victory for health advocates, ensuring continued access to essential services like cancer screenings and HIV prevention medications. However, it also grants Robert F. Kennedy Jr., the current Health and Human Services Secretary, significant authority to influence which preventive services are covered, raising concerns about potential political manipulation of health care guidelines.

#All

The Trump administration’s approach to PBMs, so far: 5 things to know

The article outlines the Trump administration’s initiatives aimed at reducing prescription drug costs, particularly concerning pharmaceutical benefit managers (PBMs). Key actions include executive orders and ongoing lawsuits targeting PBM practices. The discussion highlights the administration’s focus on transparency and competition in the pharmaceutical industry.

#Drug

OPM’s new performance management rules are (mostly) spot on

The Office of Personnel Management (OPM) has introduced new performance management rules aimed at improving federal employee evaluations. While the author supports the effort to eliminate inflated ratings, he critiques the one-size-fits-all approach that may not account for the diverse missions of various agencies. The article emphasizes the need for meaningful performance distinctions and accountability in federal employment practices.

#All

340B may move from HRSA to CMS: What you need to know

There are discussions about transferring oversight of the 340B Drug Discount Program from the Health Resources and Services Administration (HRSA) to the Centers for Medicare & Medicaid Services (CMS). This potential shift could significantly impact how the program operates and its beneficiaries.

#Hospital

J&J suffers a loss over 340B drug discount program

A federal judge ruled against Johnson & Johnson, affirming that the government agency overseeing the 340B Drug Discount Program acted within its legal authority by requiring prior approval for rebate offerings to hospitals and clinics. This decision marks a continuation of legal challenges faced by pharmaceutical companies regarding their payment models for the program.

#Hospital, #Drug

Hill Happenings

Senator launches investigation into GSK’s asthma inhaler maneuvers

Senator Maggie Hassan is investigating GlaxoSmithKline for replacing a widely used asthma inhaler with a higher-priced authorized generic to avoid Medicaid rebates, a move she claims has endangered patients’ health and led to increased hospitalizations. She has requested the company to return the inhaler to market and provide documentation regarding pricing and regulatory communications.

#Payer, #Patient

Republican plans to cap student borrowing could shatter an everyday profession

Proposed changes to federal student loan programs in the Republican tax plan are causing concern among medical professionals, as they include caps on borrowing for medical school significantly below the actual costs. The changes could disproportionately affect low-income and first-generation students, potentially exacerbating the existing physician shortage. Medical school leaders are urging Congress to reconsider these proposed limits to prevent discouraging students from pursuing careers in healthcare.

#Provider

Notable Notes

Jay Bhattacharya says he and Francis Collins ‘forgave each other’ after Covid clash

In a recent update, Jay Bhattacharya reflects on his past disagreements with Francis Collins regarding COVID-19 policies, stating that they have moved past their differences. The article also touches on the growing influence of wellness companies that align with the Make America Healthy Again movement, which are reshaping patient care by bypassing traditional healthcare systems.

#All

First 250 patients enrolled in transcatheter heart failure device trial to reduce LV size

The CORCINCH-HF U.S. pivotal trial has successfully enrolled its first 250 patients to evaluate the AccuCinch Transcatheter Left Ventricular Restoration System. This trial focuses on patients with heart failure with reduced ejection fraction (HFrEF). The study aims to assess the effectiveness of this innovative device in reducing left ventricular size, which is crucial for improving heart function.

#Device

New and Improved Navitor Makes for a Serious TAVR Contender

The Navitor transcatheter aortic valve replacement (TAVR) system is gaining recognition as a viable option in the market, based on its largest report of commercial use to date. The article discusses its performance and potential advantages, positioning it as a serious contender among existing TAVR technologies.

#Device

A closer look at world’s first TAVR patient treated with new cerebral embolic protection device

A new cerebral embolic protection device has been successfully deployed in a patient undergoing Transcatheter Aortic Valve Replacement (TAVR) for the first time. Researchers shared their findings in JACC: Case Reports, highlighting the device’s capability to cover three vessels simultaneously through the TAVR access site.

#Device

TTVR with Evoque system linked to positive real-world outcomes after 30 days

Early real-world data suggests that the FDA-approved Evoque transcatheter tricuspid valve replacement (TTVR) device is associated with positive outcomes in patients suffering from severe tricuspid regurgitation. The study indicates that patients experienced significant improvements within 30 days post-procedure, highlighting the device’s potential in managing this condition effectively.

#Device, #Patient

TriClip Raises Standing of Single-Session Mitral and Tricuspid TEER

A recent observational report highlights the efficacy of single-shot transcatheter edge-to-edge repair (TEER) technology for treating concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR). This advancement strengthens the argument for utilizing this method in clinical settings. The findings suggest improved outcomes for patients undergoing this procedure.

#Provider

SAVR With Root Enlargement Crucial for Women With Small Annuli

Research indicates that women suffering from severe native aortic stenosis (AS) experience significantly better surgical outcomes when undergoing aortic annular enlargement (AAE) compared to transcatheter aortic valve replacement (TAVR). This suggests that AAE may be a more effective option for this demographic, enhancing the surgical approach to aortic stenosis in women with smaller annuli.

#Provider

TTVR Field Grapples With the Electrophysiology Elephant in the Room

Operators in the transcatheter tricuspid valve replacement (TTVR) field acknowledged ongoing complexities related to electrophysiological issues, as early-stage research offers limited reassurance. The challenges are significant, highlighting the need for further exploration and understanding in this area of cardiac intervention.

#Provider

Female heart surgeons take home much lower salaries

Recent survey data reveals that female cardiac surgeons earn significantly less than their male counterparts, with disparities in base salaries and total compensation being particularly pronounced in this specialty compared to others in healthcare. This highlights ongoing gender pay gaps within the medical profession.

#Provider

Polymer Valve’s Strong Debut in Mitral Valve Surgery

A new polymer valve device has shown promising one-year outcomes in a small study for patients undergoing surgical mitral valve replacement. This innovation represents a significant advancement in heart valve technology, potentially improving surgical options for patients with mitral valve issues.

#Provider

TriClip Raises Standing of Single-Session Mitral and Tricuspid TEER

Recent observational studies have bolstered the case for single-session transcatheter edge-to-edge repair (TEER) procedures for patients with both mitral and tricuspid regurgitation. This advancement suggests a growing acceptance and efficacy of this less invasive surgical approach in treating multiple valve conditions simultaneously.

#Provider

Society of Thoracic Surgeons provides on-the-go risk evaluations with new mobile app

The Society of Thoracic Surgeons has launched a new mobile app for iOS and Android that offers real-time risk assessments for users. This tool aims to enhance accessibility and streamline the evaluation process for healthcare professionals.

#Provider, #Hospital, #PATIENT

Regeneron seeks to revamp the controversial relationships between pharma and patient charities

Regeneron Pharmaceuticals has announced a plan to match donations to a patient charity, aiming to improve its controversial relationship with patient assistance programs. This move follows criticism over reduced access to treatments for patients.

#Drug, #Patient

Health system CEOs rethink access to care

Health system leaders are adopting innovative strategies to improve access to healthcare, focusing on community-oriented care and leveraging technology. Initiatives include same-day appointments, online scheduling, and enhanced communication between caregivers and patients. The article emphasizes the importance of addressing access challenges to meet evolving patient needs.

#Hospital

It’s Time to Rethink What Counts as ‘High Risk’ in Medicine

The article discusses the automatic classification of certain patients as engaging in “high-risk sexual behavior” based solely on their sexual orientation, particularly for men who have sex with men. This practice, prevalent in electronic medical records, raises concerns about the accuracy and implications of such labels in medical settings. The author advocates for a more nuanced understanding of risk in medicine, suggesting that current categorizations may be overly simplistic and potentially stigmatizing.

#Provider

Heart Failure Society of America names its newest leaders and board members

Kenneth Margulies, MD, has been appointed as the new president of the Heart Failure Society of America. The new board members will officially take their positions following the HFSA Annual Scientific Meeting scheduled for September.

#Provider, #Hospital

Advanced Practice Providers Bridge Rural Healthcare Access Gap

With a critical shortage of physicians in rural America, advanced practice providers (APPs) such as nurse practitioners and physician assistants are increasingly being utilized to fill healthcare gaps. The article highlights how these providers can improve access to care, enhance patient outcomes, and alleviate the burden on overworked physicians, despite facing challenges like competition from urban areas and regulatory opposition.

#Provider, #Patient

The decades-long journey to Gilead’s twice-a-year HIV prevention drug lenacapavir

On Thursday, the FDA approved lenacapavir, to be sold as Yeztugo, for the prevention of HIV in the U.S. This essay, adapted from “Breakthrough: The Quest for Life-Changing Medicine” by William Pao, looks at lenacapavir’s decades-long journey to approval.

#All

Opinion: I Want You, Doctor, to Run for Office

There is an unspoken precedent within the medical community: don’t do anything to alienate your patients, and keep your political opinions to yourself. There are — of course — exceptions, but as a whole, I’d argue that most doctors work hard to keep their political views private. But with President Trump in the White House and HHS Secretary Robert F. Kennedy Jr. leading our nation’s health agencies, we can no longer stay silent. This administration has declared a war on science, and what is happening in Washington will directly impact our patients at home.

#Provider

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