Weekly Spotlight

HHS Leadership Crisis Deepens as Kennedy Faces Unprecedented Opposition

The Department of Health and Human Services finds itself at the center of an extraordinary institutional crisis as Secretary Robert F. Kennedy Jr. confronts mounting opposition from Congress, medical professionals, federal employees, and even his own family members. This week’s developments reveal deepening fractures in federal health policy leadership that could fundamentally reshape American public health infrastructure.

During contentious Senate Finance Committee hearings, Kennedy faced intense bipartisan scrutiny over his vaccine positions, including contradictory statements about mRNA vaccines and Operation Warp Speed. The hearings exposed cracks in Republican support, with senators from both parties challenging his fitness to lead the nation’s health agencies. Kennedy’s responses, particularly regarding vaccine science and FDA oversight, raised concerns about the accuracy of information coming from HHS leadership.

The internal revolt within HHS reached unprecedented levels as more than 1,000 current and former employees signed formal letters to Congress and President Trump demanding Kennedy’s resignation. This extraordinary action, coupled with nine former CDC directors warning of a “raging fire” of public health threats, signals a breakdown in institutional confidence rarely seen in federal health agencies.

Perhaps most striking was the public opposition from Kennedy’s own family. His sister Kerry Kennedy and nephew Joseph P. Kennedy III joined nearly two dozen medical organizations in calling for his resignation, highlighting the personal and professional isolation facing the HHS Secretary.

The turmoil has already produced significant policy changes. Kennedy dismissed CDC Director Susan Monarez amid public accusations, then appointed seven new members to the CDC’s Advisory Committee on Immunization Practices after clearing out previous members – appointments that could reshape childhood vaccination guidelines nationwide. These moves come as Democratic governors form interstate health alliances to protect vaccine access, creating a patchwork of state-level policies that could complicate national public health responses.

The implications extend beyond vaccines. The CDC faces devastating budget cuts to its National Center for Injury Prevention and Control, while mass leadership resignations signal deeper policy conflicts. Meanwhile, critical decisions on Medicare Advantage oversight, drug pricing, and research funding hang in the balance as the agency struggles with institutional paralysis.

President Trump’s continued support for Kennedy, describing his views as offering “different perspectives,” suggests these tensions will persist. As Congress debates healthcare funding with enhanced ACA subsidies set to expire and critical programs facing uncertainty, the leadership crisis at HHS threatens to complicate every major health policy decision facing the administration.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS Extends and Enhances AHEAD All-Payer Model Through 2035 with Major State Implementation Improvements

The Centers for Medicare & Medicaid Services (CMS) announced comprehensive updates to the Achieving Healthcare Efficiency through Accountable Design (AHEAD) Model on September 2, extending the Medicare payment demonstration program through December 31, 2035. The enhanced all-payer model introduces significant modifications to improve state-level implementation, including new policies promoting healthcare provider competition and accountability, enhanced Medicare and Medicaid payment coordination across health systems, and financial incentives for Original Medicare beneficiaries in participating regions. States can now receive up to $12 million in federal funding to support program implementation and care quality improvements. The reforms focus on preventive care initiatives and population health outcomes while managing healthcare costs through state-led Medicare payment reform and improved health system efficiency.
Source(s):
CMS tweaks AHEAD all-payer model for states (Healthcare Dive)
CMS updates AHEAD model: 6 things to know (Becker’s Hospital Review)
Innovation Insight: CMS Announces Changes to Achieving Healthcare Efficiency through Accountable Design (AHEAD) Model to Improve Quality, Promote Transparency, and Decrease Costs (cms.gov)
Cms announces changes to achieving healthcare efficiency through accountable design (AHEAD) model (MarketScreener)
Tags: #PROVIDER, #PAYER, #HOSPITAL

CMS broadens access to catastrophic exchange plans

The Centers for Medicare & Medicaid Services (CMS) has expanded eligibility criteria for catastrophic health insurance coverage through ACA exchanges, broadening patient access to lower-premium, high-deductible health plans. This policy change could impact insurance coverage affordability for consumers who previously didn’t qualify for these bare-bones plans, potentially affecting health plan enrollment patterns and healthcare provider reimbursement structures in exchange markets.
Source(s):
CMS broadens access to catastrophic exchange plans (Modern Healthcare)
Tags: #PATIENT, #PAYER, #PROVIDER

ACHP Highlights Discrepancy In MA RA Pay; Calls On CMS To Radically Reform Program

The Alliance of Community Health Plans (ACHP) is urging CMS and the Trump administration to implement comprehensive reforms to the Medicare Advantage risk adjustment program, citing significant payment discrepancies that impact health plan reimbursement and Medicare coverage for beneficiaries.
Source(s):
ACHP Highlights Discrepancy In MA RA Pay; Calls On CMS To Radically Reform Program (InsideHealthPolicy Daily News)
Tags: #PAYER, #PROVIDER

CMS’s Competitive Bidding Proposal Ignores Medical Reality

The Centers for Medicare & Medicaid Services (CMS) faces criticism from healthcare providers for a competitive bidding proposal that prioritizes cost reduction over clinical needs, potentially compromising Medicare payment adequacy and patient access to quality care. A former FDA associate commissioner warns the proposal ignores medical realities and urges CMS to balance fiscal responsibility with patient care requirements, raising concerns about Medicare reimbursement impacts on healthcare providers and beneficiary health outcomes.
Source(s):
CMS’s Competitive Bidding Proposal Ignores Medical Reality (MedPageToday.com)
Tags: #PROVIDER, #PATIENT, #PAYER

CMMI Unveils Job Openings Following RIF, Firings; Waives Traditional Hiring Reqs

The CMS Innovation Center (CMMI) has posted new positions for economist and health insurance specialist roles following recent workforce reductions, with expedited hiring timelines of less than one week for applications. The agency is waiving traditional hiring requirements as part of a strategic shift to rebuild capabilities and advance Medicare and Medicaid innovation programs, potentially impacting healthcare delivery transformation and payment model development.
Source(s):
CMMI Unveils Job Openings Following RIF, Firings; Waives Traditional Hiring Reqs (InsideHealthPolicy Daily News)
Tags: #PROVIDER, #PAYER, #HOSPITAL

CMS’ plan to hire Medicare Advantage auditors appears to stall

The Centers for Medicare & Medicaid Services (CMS) has encountered delays in its initiative to hire independent auditors for Medicare Advantage plan oversight, potentially impacting program integrity and beneficiary protections. The stalled hiring process raises concerns about CMS’s ability to strengthen monitoring of Medicare Advantage health plans and ensure proper insurance coverage compliance.
Source(s):
CMS’ plan to hire Medicare Advantage auditors appears to stall (Modern Healthcare)
Tags: #PAYER, #PATIENT

CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F)

The Centers for Medicare & Medicaid Services has finalized the Interoperability and Prior Authorization Rule, requiring health plans to streamline prior authorization processes and improve data sharing between healthcare providers and payers. The rule aims to reduce administrative burden on physicians and medical practices while enhancing patient access to care and Medicare coverage decisions.
Source(s):
CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) (CMS)
Tags: #PROVIDER, #PAYER, #PATIENT

Food and Drug Administration (FDA)

FDA’s Move Away from Formal Advisory Committees to Ad-Hoc Expert Panels Sparks Transparency and Accountability Concerns

The FDA has increasingly replaced formal advisory committees with ad-hoc expert panels for pharmaceutical and medical device decisions, raising significant transparency and accountability concerns among healthcare stakeholders. These informal panels lack standard conflict-of-interest reviews, recorded votes, and formal procedures required for traditional advisory committees, potentially undermining regulatory integrity and scientific rigor in FDA approval processes. The shift affects critical health decisions including talc safety regulations and antidepressant medication policies, with critics arguing this regulatory change weakens standards that protect patient access to safe treatments while eroding public trust in pharmaceutical oversight.
Source(s):
Opinion: The FDA’s pivot from ad comms to ‘expert’ panels is bad medicine (Stat)
The FDA’s Shift from Advisory Committees to Expert Panels is a Detriment to Transparency (Stat)
Tags: #DRUG, #DEVICE, #PATIENT

Patient comfort drives demand for next-gen medical devices

The healthcare industry is experiencing increased demand for next-generation medical devices driven by patient comfort priorities, with manufacturers innovating to enhance user experience. This trend is expected to influence future FDA device clearance processes, Medicare reimbursement strategies, and regulatory frameworks as device manufacturers adapt to meet evolving patient access and care quality expectations in medical practice settings.
Source(s):
Patient comfort drives demand for next-gen medical devices (Modern Healthcare)
Tags: #DEVICE, #PATIENT, #PROVIDER

In major shift, FDA to start releasing rejection letters shortly after they’re issued

The FDA announced a major transparency shift, immediately releasing complete response letters (rejection letters) to pharmaceutical companies upon issuance. This policy change includes public disclosure of 89 previously undisclosed FDA rejection letters from 2024-2025, significantly impacting drug manufacturers and enhancing visibility into the FDA approval process for prescription medications and pharmaceutical development.
Source(s):
In major shift, FDA to start releasing rejection letters shortly after they’re issued (Stat)
Tags: #DRUG, #DEVICE, #PATIENT

FDA Pulls RFK Jr. Critic Off Its Vaccine Advisory Panel

The FDA has removed pediatric vaccine expert Paul Offit, MD, from its vaccine advisory panel after two terms of service. Offit has been a vocal critic of HHS Secretary Robert F. Kennedy Jr.’s approach to public health and vaccine policy. The decision raises concerns about potential political influence on FDA vaccine recommendations and federal public health policy under the new HHS leadership.
Source(s):
FDA Pulls RFK Jr. Critic Off Its Vaccine Advisory Panel (MedPageToday.com)
Tags: #PROVIDER, #PATIENT, #DRUG

CVS Health, Walgreens shift COVID vaccine policies as providers say new FDA criteria create barriers for patients

CVS Health and Walgreens are adjusting their COVID-19 vaccination policies following new FDA criteria that healthcare providers say create patient access barriers. The pharmacy chains’ policy shifts highlight ongoing challenges in vaccine distribution and patient access to preventive care services amid evolving federal regulatory requirements.
Source(s):
CVS Health, Walgreens shift COVID vaccine policies as providers say new FDA criteria create barriers for patients (Fierce Healthcare)
Tags: #PATIENT, #PROVIDER, #DRUG

AI-driven drug discovery picks up as FDA pushes to reduce animal testing

The FDA is advancing AI-driven pharmaceutical drug discovery technologies to reduce animal testing requirements, potentially accelerating FDA approval processes and lowering development costs for drug manufacturers. This regulatory shift toward alternative testing methods could streamline medication development timelines and improve efficiency in bringing new prescription treatments to market.
Source(s):
AI-driven drug discovery picks up as FDA pushes to reduce animal testing (Reuters)
Tags: #DRUG, #DEVICE

FDA commissioner says agency is looking into question of pediatric deaths from Covid vaccines

FDA Commissioner Marty Makary announced the agency is investigating reports of pediatric deaths potentially linked to Covid-19 vaccines, focusing on establishing causation in vaccine safety. The FDA investigation highlights ongoing pharmaceutical safety monitoring and regulatory oversight of vaccine adverse events, with implications for pediatric patient access and public health policy decisions regarding childhood immunization programs.
Source(s):
FDA commissioner says agency is looking into question of pediatric deaths from Covid vaccines (Stat)
Tags: #DRUG, #PATIENT, #PROVIDER

What Some Terms Used to Describe Potential Treatments Mean

The FDA has published clarifications on terminology related to potential treatments, aiming to enhance understanding among healthcare providers and improve pharmaceutical regulatory communication. The guidance addresses treatment-related language to support physician decision-making and patient access to FDA-approved therapies.
Source(s):
What Some Terms Used to Describe Potential Treatments Mean (FDA)
Tags: #DRUG, #PROVIDER, #PATIENT

Health and Human Services

RFK Jr. Faces Mounting Opposition as HHS Secretary Over Vaccine Policies and Agency Leadership

HHS Secretary Robert F. Kennedy Jr. encountered intense bipartisan scrutiny during Senate Finance Committee hearings over his controversial vaccine positions, including opposition to mRNA vaccines and contradictory statements about Operation Warp Speed. The contentious sessions exposed cracks in Republican support and growing congressional concerns about his fitness to lead federal health agencies. Kennedy faced criticism for providing inaccurate vaccine information and undermining public trust in CDC and FDA guidance. Nearly two dozen medical organizations demanded his resignation, while his own family members, including sister Kerry Kennedy and nephew Joseph P. Kennedy III, publicly called for him to step down. Despite the mounting opposition from lawmakers, medical societies, and family, President Trump reaffirmed his support for Kennedy, describing his views as offering ‘different perspectives’ in health discussions. The controversy has raised significant concerns about the future direction of federal health policy, CDC vaccine programs, FDA oversight, and public health messaging under Kennedy’s leadership of the Department of Health and Human Services.
Source(s):
Senators Unleash on R.F.K. Jr. (The New York Times)
Now, even Senate Republicans are pushing back on Kennedy’s vaccine views (Stat)
Trump backs RFK Jr. following tense Senate hearing (POLITICO – TOP Stories)
What RFK Jr. got wrong about vaccines during Senate hearing (POLITICO – Health Care)
What happened at RFK Jr.’s Senate hearing in 300 words (Stat)
Multiple Medical Societies Demand RFK Jr.’s Resignation (MedPageToday.com)
What is happening at the CDC? (Stat)
The big takeaways from health secretary RFK Jr.’s contentious Senate hearing (Stat)
5 Takeaways From RFK Jr.’s Senate Hearing (The New York Times)
RFK Jr. Faces Senate Grilling After Vaccine Changes and C.D.C. Shake-Up (The New York Times)
Here Are the Senators Who Want RFK Jr. Out of HHS (MedPageToday.com)
7 burning questions for RFK Jr. as he faces senators on CDC turmoil and more (Stat)
Tensions Rise in Senate Hearing with Health Secretary Robert F. Kennedy Jr. (Stat)
Senate Republicans Begin to Push Back Against Kennedy’s Vaccine Perspectives (Stat)
Highlights from the Chaotic Senate Hearing with R.F.K. Jr. (Stat)
R.F.K. Jr. Faces Intense Scrutiny at Senate Hearing (The New York Times)
What RFK Jr. got wrong about vaccines during Senate hearing (POLITICO – Health Care)
RFK Jr. Botches Basic Facts at Senate Hearing (MedPage Today Primary Care)
Trump backs RFK Jr. following tense Senate hearing (POLITICO – TOP Stories)
RFK Jr.’s sister, nephew call for him to resign from HHS (Stat)
Kennedy, Rejecting Data, Fuels Distrust of His Own Agencies (The New York Times)
Tags: #ALL

Kennedy Overhauls CDC Vaccine Advisory Panel with Seven New Appointees Following Mass Dismissals

HHS Secretary Robert F. Kennedy Jr. has appointed seven new members to the CDC’s Advisory Committee on Immunization Practices (ACIP) after dismissing previous committee members in June, marking a significant shift in federal vaccine policy oversight. The new appointees have expressed skepticism about vaccine recommendations, potentially reshaping CDC vaccination guidelines that influence physician prescribing practices, insurance coverage decisions, and patient access to immunizations across healthcare systems. This restructuring represents a fundamental change in public health policy direction under the new HHS leadership.
Source(s):
Kennedy prepares to name new vaccine panel members (POLITICO – Health Care)
Kennedy to Add New Members to Vaccine Advisory Panel (The New York Times)
RFK Jr. Picks 7 New Members for CDC’s Vaccine Panel: Here’s What We Know (MedPageToday.com)
Tags: #ALL

HHS Restores Deleted Federal Health Information Following Legal Settlement Over Website Content Removal

The Department of Health and Human Services reached a lawsuit settlement requiring restoration of federal public health information previously deleted from government websites, including critical data on maternal health outcomes and opioid addiction treatment programs. The content removal was part of broader efforts to eliminate diversity, equity, and inclusion materials from federal sites, prompting multiple legal challenges from healthcare advocacy groups. This restoration addresses transparency concerns over patient access to government health resources and provider guidance materials, representing a significant development for public health policy communication and data-driven healthcare decision-making by health systems.
Source(s):
HHS restoring deleted health information following legal challenge (Health Exec)
Trump Admin Throws Up Hands, Pledges to Restore HHS Websites (MedPageToday.com)
HHS restoring deleted health information following legal challenge (Health Exec)
Tags: #PATIENT, #PROVIDER, #HOSPITAL

Over 1,000 HHS Employees Demand RFK Jr.’s Resignation Amid Public Health Policy Turmoil

More than 1,000 current and former Department of Health and Human Services employees have signed formal letters to Congress and President Trump demanding Secretary Robert F. Kennedy Jr.’s resignation. The unprecedented internal revolt cites concerns over public health misinformation, compromised agency integrity, and ongoing health policy controversies. The employee coalition’s action follows significant CDC leadership changes and raises critical questions about federal health agency oversight, credibility among healthcare providers, and the future direction of U.S. public health policy under the current administration.
Source(s):
Over 1,000 HHS employees ask Congress, Trump to depose RFK (Health Exec)
HHS Employees Call for RFK Jr. to Resign (MedPageToday.com)
Tags: #ALL

CDC Leadership Turmoil: Kennedy Fires Director but Adopts Her Reform Plans Amid Public Dispute

HHS Secretary Robert F. Kennedy Jr. dismissed CDC Director Susan Monarez amid public accusations and counter-accusations about the circumstances of her firing, with Kennedy denying he pressured her on health leadership decisions while accusing her of lying. Despite the acrimonious leadership change, Kennedy subsequently outlined CDC reform proposals that mirror Monarez’s previously confidential recommendations, suggesting potential continuity in agency restructuring plans despite the dramatic personnel shift and highlighting ongoing tensions over public health policy direction under the new HHS administration.
Source(s):
Kennedy, in striking turn, accuses ousted CDC director of lying about leadup to her firing (Stat)
STAT+: After ousting CDC’s director, RFK Jr. mirrors her ideas to reform the agency (Stat)
Tags: #ALL

Trump Administration Partners with Gilead to Distribute Revolutionary HIV Prevention Drug Through PEPFAR Despite Budget Uncertainty

The Trump administration has confirmed a partnership with Gilead Sciences and The Global Fund to distribute lenacapavir, a groundbreaking HIV prevention medication, to up to 2 million people in low- and middle-income countries through PEPFAR. The antiviral drug provides HIV protection with a single administration every six months, potentially transforming global access to HIV prevention. However, the initiative faces significant uncertainty as PEPFAR confronts substantial budget cuts, with only half of the program’s $6 billion budget currently appropriated by Congress, raising concerns about long-term sustainability and health outcomes in affected regions amid potential foreign aid reductions.
Source(s):
Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug (Stat)
Trump administration confirms plan for PEPFAR to distribute Gilead’s new HIV prevention drug (Stat)
Tags: #DRUG, #PATIENT

Former NIH Officials File Whistleblower Complaints Alleging Political Interference in Federal Research Funding

Two former senior NIH officials filed whistleblower complaints alleging the Trump administration retaliated against them for opposing politically-motivated research grant terminations and interference in vaccine development. The complaints detail how political appointees allegedly undermined scientific integrity at the National Institutes of Health, including a $500 million flu vaccine program that bypassed scientific peer review processes, violating NIH standards. The allegations raise broader concerns about federal research funding oversight, potential illegal interference in NIH’s scientific grant processes, and the impact on healthcare research and medical advancement programs.
Source(s):
Two former top NIH officials say they were forced out in retaliation for objecting to grant terminations (Stat)
Two former top NIH officials say they were forced out in retaliation for objecting to grant terminations (Stat)
Tags: #DRUG, #DEVICE, #PROVIDER

Democratic Governors Form Interstate Health Alliances To Counter GOP Vaccine Restrictions And Trump Administration Policies

Democratic governors are establishing coordinated interstate health alliances to protect patient access to vaccines and immunizations amid growing political polarization over public health policy. The coalitions, including a formal alliance between Washington, Oregon, and California governors, aim to counter Republican-led state vaccination restrictions and perceived threats from Trump administration policies, particularly concerning CDC restructuring and anti-vaccine initiatives. These alliances create frameworks for state-level public health coordination independent of federal HHS guidance, potentially impacting CDC vaccination programs and creating interstate healthcare policy conflicts as COVID-19 cases rise and vaccination access becomes increasingly politicized across state lines.
Source(s):
As Some GOP States Restrict Vaccines, Dem Govs Launch Alliance To Protect Access (InsideHealthPolicy Daily News)
Washington, Oregon and California governors form a health alliance in rebuke of Trump administration (Stat)
Tags: #PATIENT, #PROVIDER, #PAYER

CDC Crisis Deepens as Budget Cuts, Leadership Exodus, and Policy Conflicts Under RFK Jr. Threaten Public Health Infrastructure

The CDC faces mounting institutional crisis as devastating budget cuts to the National Center for Injury Prevention and Control follow a violent campus attack, while mass leadership resignations signal policy conflicts with HHS Secretary Robert F. Kennedy Jr. Nine former CDC directors warn Congress of a ‘raging fire’ of public health threats from significant agency layoffs and cuts to essential programs, expressing concerns over weakened disease surveillance, violence prevention, injury monitoring, and emergency preparedness capabilities that leave critical healthcare infrastructure vulnerable amid ongoing misinformation campaigns.
Source(s):
Opinion: CDC’s Injury Center has been devastated by cuts. Here’s what we’ve lost (Stat)
CDC Resignations: These Are the Lines That Were Crossed (MedPageToday.com)
Nine former CDC leaders warn of ‘raging fire’ ignited by RFK (Health Exec)
Tags: #ALL

HHS to crack down on data blocking

The U.S. Department of Health and Human Services (HHS) announced enhanced enforcement measures to combat healthcare data blocking, strengthening patient access rights and data interoperability requirements. The initiative targets healthcare providers and health systems that restrict patient access to their medical information, aiming to improve care quality and patient engagement through better data sharing compliance.
Source(s):
HHS to crack down on data blocking (Becker’s Hospital Review)
Tags: #HOSPITAL, #PROVIDER, #PATIENT

Not Sure Where to Turn for Trusted Vaccine Guidance?

This fall, Americans face critical vaccination decisions for flu, COVID-19, and RSV amid public health debates over immunization guidance. Healthcare providers and patients need reliable CDC vaccination recommendations to ensure patient access to preventive care and improve health outcomes through evidence-based immunization policies.
Source(s):
Not Sure Where to Turn for Trusted Vaccine Guidance? (MedPageToday.com)
Tags: #PATIENT, #PROVIDER, #PAYER

STAT+: A closely watched legal battle over NIH funding cuts could settle soon

A legal dispute over NIH grant terminations is nearing settlement after a court ruling found some funding cuts illegal and ordered grant reinstatements. The case involves federal research funding authority and could significantly impact public health research funding, NIH operational procedures, and healthcare policy research programs moving forward.
Source(s):
STAT+: A closely watched legal battle over NIH funding cuts could settle soon (Stat)
Tags: #ALL

Big shakeups to the childhood vaccination schedule could be nearing

Under Health Secretary Robert F. Kennedy Jr.’s leadership, the CDC may implement significant changes to childhood vaccination policies following the dismissal of the previous CDC director. Healthcare providers and public health officials express concerns that new vaccination recommendations could diverge from established scientific consensus, potentially affecting patient access to preventive care and health outcomes for children nationwide.
Source(s):
Big shakeups to the childhood vaccination schedule could be nearing (Stat)
Tags: #PATIENT, #PROVIDER, #ALL

HHS Drives Reform to Restore Patient-Centered Care, Announces Request for Nominations of Members to Serve on Federal Healthcare Advisory Committee

The Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) are establishing a new Healthcare Advisory Committee to deliver strategic recommendations for patient-centered care reforms across Medicare and Medicaid programs. The committee will address chronic disease management, healthcare provider regulatory burden reduction, and care delivery modernization. HHS is seeking nominations for committee members during a 30-day open period, emphasizing the administration’s commitment to expert-driven healthcare policy reform that impacts patient access, care quality, and health outcomes for Medicare and Medicaid beneficiaries.
Source(s):
HHS Drives Reform to Restore Patient-Centered Care, Announces Request for Nominations of Members to Serve on Federal Healthcare Advisory Committee (cms.gov)
Tags: #ALL

Trump pressures drugmakers amid CDC turmoil

President Trump is pressuring pharmaceutical manufacturers during ongoing CDC organizational changes, potentially affecting drug pricing policies and prescription medication availability. The pressure on drugmakers could have broader implications for pharmaceutical industry regulation and patient access to medications.
Source(s):
Trump pressures drugmakers amid CDC turmoil (Stat)
Tags: #DRUG, #PATIENT

Nobel Laureates, Top U.S. Scientists, Sanders Demand RFK Jr. Resign; Former CDC Chiefs Blast RFK

A coalition of Nobel laureates, prominent scientists, and former CDC directors is demanding the resignation of HHS Secretary Robert F. Kennedy Jr., raising concerns about public health leadership and policy direction under the current administration. The unprecedented scientific opposition highlights potential conflicts over evidence-based healthcare policy and federal health agency oversight.
Source(s):
Nobel Laureates, Top U.S. Scientists, Sanders Demand RFK Jr. Resign; Former CDC Chiefs Blast RFK (InsideHealthPolicy Daily News)
Tags: #ALL

Reforming NIH: A blueprint for 21st century medical research

The National Institutes of Health (NIH), which oversees nearly $50 billion in annual biomedical research funding, faces a proposed 40% budget reduction under the Trump administration. This cut would significantly impact ongoing research grants, medical research infrastructure, and NIH staff, raising concerns about transparency in federal research funding decisions and oversight of critical health outcomes research that affects patient access to new treatments and medical advances.
Source(s):
Reforming NIH: A blueprint for 21st century medical research (Stat)
Tags: #ALL

CDC’s vaccine information no longer entirely trustworthy, former director says

Former CDC Director Rochelle Walensky raised concerns about the reliability of vaccine information currently available on the CDC website, suggesting the agency’s guidance may no longer be entirely trustworthy. This critique from a former agency leader highlights potential issues with federal health communication and public health messaging that could impact patient access to accurate vaccination information and healthcare provider recommendations.
Source(s):
CDC’s vaccine information no longer entirely trustworthy, former director says (Stat)
Tags: #PATIENT, #PROVIDER, #ALL

Heard on the Hill

Congress faces high-stakes healthcare policy battles in government funding fight as key programs and ACA subsidies hang in balance

As Congress approaches the September 30 government funding deadline, critical healthcare policies face unprecedented uncertainty with warring factions divided over funding levels. Key battles center on extending essential healthcare programs affecting Medicare and Medicaid reimbursements, hospital system payments, and patient access to care. Most critically, enhanced ACA premium subsidies are set to expire, threatening premium increases for millions starting January if not renewed. The funding standoff pits fiscal hawks and the White House pushing static funding against Democrats and some Republicans seeking short-term extensions, with stakes particularly high for federal health agencies including HHS and CMS coordination on program implementation.
Source(s):
The key health care policies at stake in Congress’ government funding fight (Stat)
The key health care fights to watch in Congress (Stat)
Inside Congress’ warring factions over how to fund the government (POLITICO – TOP Stories)
Tags: #ALL

House Republicans Chart Selective Path on Federal Health Funding: Preserve NIH Research While Cutting Public Health Programs

House Republicans’ fiscal 2026 appropriations bill reveals strategic federal health funding priorities, maintaining NIH funding at $48 billion despite Trump administration proposals for $18 billion cuts, while simultaneously reducing CDC funding and eliminating AHRQ entirely. The legislation proposes $1.7 billion cuts to HHS HIV programs, completely eliminating the Ending the HIV Epidemic initiative and reducing Ryan White programs by 20%. These decisions signal a congressional preference for medical research funding over public health infrastructure and prevention programs, potentially impacting healthcare providers, vulnerable populations, and evidence-based care nationwide while rejecting broader health agency reorganization plans.
Source(s):
GOP lawmakers uphold NIH funding: 4 federal health updates (Becker’s Hospital Review)
House Proposes HIV Cuts, Eliminating Trump’s 2019 EHE Initiative (InsideHealthPolicy Daily News)
House Funding Bill Rejects Trump’s Proposed NIH Cuts, But Cuts CDC (InsideHealthPolicy Daily News)
House bill cuts HHS budget but excludes RFK Jr.’s reorganization, maintains NIH funding (Stat)
Tags: #ALL

Can anyone get a Covid shot if they want one? No

During a Senate hearing, HHS Secretary Robert F. Kennedy Jr. faced scrutiny over COVID-19 vaccine accessibility limitations, with prescription requirements and insurance coverage gaps creating patient access barriers. The discussion highlighted ongoing pharmaceutical policy challenges around vaccine distribution and Medicare/Medicaid coverage decisions affecting public health outcomes.
Source(s):
Can anyone get a Covid shot if they want one? No (Stat)
Tags: #DRUG, #PATIENT, #PAYER

House Republicans launch bill to extend health subsidies past midterms

House Republicans introduced legislation to extend enhanced Affordable Care Act premium tax credits beyond 2022 midterm elections, addressing insurance coverage concerns as subsidies face year-end expiration. The bill represents a political strategy to maintain health plan affordability and patient access while navigating electoral pressures around healthcare policy.
Source(s):
House Republicans launch bill to extend health subsidies past midterms (POLITICO)
Tags: #PATIENT, #PAYER, #PROVIDER

PhRMA Launches New 340B Ad As House Bill Markups Are Pending

PhRMA launched a television ad campaign targeting lawmakers to address 340B drug discount program concerns before key provisions expire September 30. The pharmaceutical industry advocacy effort coincides with pending House bill markups, highlighting ongoing tensions over prescription drug pricing policies and hospital reimbursement structures that affect patient access to medications.
Source(s):
PhRMA Launches New 340B Ad As House Bill Markups Are Pending (InsideHealthPolicy Daily News)
Tags: #DRUG, #HOSPITAL, #PATIENT

House Oversight Expands PBM Probe To International GPOs

The House Oversight & Accountability Committee is expanding its pharmacy benefit manager (PBM) investigation to include international group purchasing organizations, examining allegations that PBMs use these entities to retain additional revenue and circumvent federal regulations. The probe focuses on potential impacts to prescription drug pricing and pharmaceutical market transparency, raising concerns about PBM accountability in Medicare and Medicaid programs. This broadened inquiry reflects ongoing scrutiny of PBM practices affecting patient access to medications and insurance coverage decisions across U.S. health plans.
Source(s):
House Oversight Expands PBM Probe To International GPOs (InsideHealthPolicy Daily News)
Tags: #DRUG, #PAYER, #PATIENT

Rural Hospitals Expected to Lose Money From Trump’s Bill, Despite RFK Jr.’s Promise

Rural hospitals face projected billion-dollar losses from President Trump’s tax and spending cut legislation, threatening already financially vulnerable healthcare facilities despite RFK Jr.’s previous assurances. The policy changes could impact hospital reimbursement and Medicare payments, potentially affecting patient access to care in underserved communities where many rural health systems operate on thin margins.
Source(s):
Rural Hospitals Expected to Lose Money From Trump’s Bill, Despite RFK Jr.’s Promise (MedPageToday.com)
Tags: #HOSPITAL, #PROVIDER, #PATIENT

Lawmaker calls for pause of pilot program adding prior authorization for traditional Medicare services

A member of Congress from Ohio is urging CMS to halt a pilot program that introduces prior authorization requirements for certain traditional fee-for-service Medicare services, including knee arthroscopy for osteoarthritis and electrical nerve stimulator implants. The program aims to reduce denied claims but raises concerns about patient access to care and potential delays in treatment for Medicare beneficiaries seeking these medical procedures.
Source(s):
Lawmaker calls for pause of pilot program adding prior authorization for traditional Medicare services (Becker’s Hospital Review)
Tags: #PATIENT, #PROVIDER, #PAYER

Notable Notes

National Academies Report Recommends 53 Policy Changes to Streamline Federal Research Regulations Under Trump Administration

A comprehensive National Academies report reveals U.S. federally funded researchers spend over 40% of their time on administrative tasks due to excessive regulations, significantly hampering scientific productivity and competitiveness. The report recommends 53 specific policy changes to streamline federal research regulations, including establishing a Federal Research Policy Board to coordinate cross-agency processes across FDA, NIH, and HHS. These recommendations could dramatically impact research funding efficiency, reduce regulatory compliance costs, accelerate medical research approvals, and enhance healthcare innovation timelines while maintaining necessary oversight. The reforms specifically target optimizing American science funding efficiency under the Trump administration’s regulatory framework.
Source(s):
National Academies report outlines ways Trump administration could simplify research regulations (Stat)
Simplifying Research Regulations and Policies: Optimizing American Science (National Academies Press)
Tags: #ALL

Health Care Costs for Workers Begin to Climb

A recent survey shows employers expect significant health benefit cost increases for the upcoming year, with employees facing higher out-of-pocket expenses through increased deductibles and copayments. This shift in insurance coverage burden could impact patient access to care, employee retention, and healthcare utilization decisions as health plans transfer more financial responsibility to workers.
Source(s):
Health Care Costs for Workers Begin to Climb (The New York Times)
Tags: #ALL

Common nasal spray may lower COVID-19 risk: Study

A German study of 450 participants found that azelastine, an over-the-counter nasal spray medication, reduced COVID-19 infection risk by delaying onset and reducing symptomatic cases. The pharmaceutical research from Saarland University Hospital suggests potential patient access benefits for this existing antihistamine drug in pandemic prevention strategies.
Source(s):
Common nasal spray may lower COVID-19 risk: Study (Becker’s Hospital Review)
Tags: #DRUG, #PATIENT, #PROVIDER

More Advanced Prostate Cancers After USPSTF Guideline Change

A report from the American Cancer Society shows a 3% annual increase in prostate cancer diagnoses between 2014-2021, with more advanced cases detected following changes to USPSTF screening guidelines. The findings highlight how guideline modifications impact patient access to early detection, care quality, and health outcomes for men’s cancer screening programs.
Source(s):
More Advanced Prostate Cancers After USPSTF Guideline Change (MedPageToday.com)
Tags: #PATIENT, #PROVIDER

Cigna invests $3.5B in specialty pharmacy company

Cigna’s subsidiary, Evernorth Health Services, invested $3.5 billion in Shields Health Solutions, a specialty pharmacy company that partners with health systems to manage in-house pharmaceutical services. This strategic acquisition expands Cigna’s health plan capabilities in specialty medication management and prescription drug services, potentially impacting patient access to specialized treatments and hospital reimbursement models for high-cost pharmaceuticals within health system networks.
Source(s):
Cigna invests $3.5B in specialty pharmacy company (Becker’s Hospital Review)
Tags: #PAYER, #DRUG, #HOSPITAL

Opinion: Republicans, take note: Voters trust Democrats more on vaccines

Despite low approval ratings for Democrats, recent polling indicates that voters trust them more than Republicans on healthcare and vaccine policy. This public perception challenge could impact Republican electoral strategies as they navigate health policy positions, particularly around vaccine mandates, CDC guidance, and public health messaging in upcoming elections.
Source(s):
Opinion: Republicans, take note: Voters trust Democrats more on vaccines (Stat)
Tags: #ALL

At the farmers market, slashed benefits threaten MAHA’s food-as-medicine goal

Federal safety net program cuts are undermining patient access to nutritious foods through farmers market programs in Pennsylvania, directly conflicting with the Make America Healthy Again initiative’s food-as-medicine approach. The benefit reductions threaten health outcomes for low-income populations who rely on these nutrition programs to manage chronic conditions, highlighting tensions between fiscal policy and public health goals in federal food assistance programs.
Source(s):
At the farmers market, slashed benefits threaten MAHA’s food-as-medicine goal (Stat)
Tags: #PATIENT, #PROVIDER

Analysis of NEJM Abstracts Confirms the Value of Peer Review

A MedPageToday analysis of New England Journal of Medicine randomized trial abstracts revealed that 59% showed improvement through peer review processes, highlighting quality assurance mechanisms that impact medical research standards and evidence-based healthcare policy development for physicians and healthcare providers.
Source(s):
Analysis of NEJM Abstracts Confirms the Value of Peer Review (MedPageToday.com)
Tags: #PROVIDER

Gilead wants state AIDS drug programs to pay significant price hikes for HIV meds

Gilead Sciences plans significant pharmaceutical drug pricing increases for HIV medications distributed through state AIDS Drug Assistance Programs (ADAP), potentially reducing patient access to critical prescription treatments for vulnerable populations. The price hikes could impact Medicaid and state-funded programs serving low-income HIV patients who rely on these life-saving medications.
Source(s):
Gilead wants state AIDS drug programs to pay significant price hikes for HIV meds (Stat)
Tags: #DRUG, #PATIENT, #PAYER

Trump Plans a Hefty Tax on Imported Drugs, Risking Higher Prices and Shortages

President Trump’s proposed tariffs on imported pharmaceutical products could significantly impact drug pricing and medication access in the U.S. market. The policy raises concerns about potential prescription drug shortages and increased costs for patients, with implications for healthcare providers, insurance coverage, and overall patient access to essential medications. The pharmaceutical industry faces uncertainty as import restrictions could disrupt supply chains and affect drug availability across health systems.
Source(s):
Trump Plans a Hefty Tax on Imported Drugs, Risking Higher Prices and Shortages (MedPageToday.com)
Tags: #DRUG, #PATIENT, #PAYER

Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list

The World Health Organization has added essential diabetes and cystic fibrosis medications to its global essential medicines list, including pharmaceutical treatments from Eli Lilly’s Mounjaro and Novo Nordisk, marking a significant policy shift that could improve patient access to these prescription drugs worldwide and influence drug pricing negotiations in developing countries.
Source(s):
Patient groups cheer as the WHO adds diabetes and cystic fibrosis drugs to its essential medicines list (Stat)
Tags: #DRUG, #PATIENT

Fracture Protection May Be Another Benefit of GLP-1 Receptor Agonists

A recent study indicates that GLP-1 receptor agonists, pharmaceutical medications commonly used for managing type 2 diabetes, may also reduce fracture risk among older patients. This potential dual benefit could impact prescription patterns, patient access, and health outcomes for diabetic patients, with implications for Medicare coverage and healthcare provider treatment protocols.
Source(s):
Fracture Protection May Be Another Benefit of GLP-1 Receptor Agonists (MedPageToday.com)
Tags: #DRUG, #PROVIDER, #PAYER