Weekly Spotlight
This week saw multiple fronts of disruption converge across HHS, FDA, and NIH. The Supreme Court’s decision to uphold $783 million in cuts to NIH diversity programs signals a fundamental shift in federal research priorities, potentially affecting clinical trial access and health equity initiatives nationwide. Simultaneously, HHS Secretary Robert F. Kennedy Jr.’s sweeping reforms—including plans to eliminate conflicts of interest in FDA advisory committees, cancel mRNA vaccine research contracts, and issue legal warnings to physicians who deviate from CDC guidelines—are creating unprecedented turbulence within federal health agencies. The revelation that over 750 HHS employees have demanded Kennedy stop spreading health misinformation following a CDC shooting incident underscores the internal tensions threatening agency operations.
Perhaps most tellingly, major medical societies are now openly breaking with federal guidance, as evidenced by the American Academy of Pediatrics and American College of Obstetricians and Gynecologists issuing COVID-19 vaccination recommendations that directly contradict CDC and FDA guidance. This rare fracture between professional medical organizations and federal agencies creates a complex landscape where healthcare providers must navigate conflicting guidance while facing potential legal liability. The convergence of budget cuts, ideological reforms, workforce disruption, and professional dissent suggests we’re witnessing not just policy changes but a fundamental restructuring of how federal health agencies operate and interact with the healthcare ecosystem. Stakeholders across all sectors should prepare for continued volatility as these changes ripple through reimbursement models, regulatory processes, and care delivery standards.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
How Trump May Use Democrats’ Drug-Price Negotiation Law
President Trump is positioned to leverage Medicare’s new pharmaceutical price negotiation authority, established under Democratic legislation, to achieve significant drug pricing reductions. The administration’s implementation strategy for this Medicare program remains uncertain, with potential reliance on existing CMS mechanisms to negotiate lower prescription medication costs for beneficiaries.
Source(s):
How Trump May Use Democrats’ Drug-Price Negotiation Law (Stat)
Tags: #DRUG, #PAYER, #PATIENT
CMS Launches AI-Powered Competition to Combat Medicare Fraud Through Advanced Claims Analytics
The Centers for Medicare & Medicaid Services (CMS) has launched the ‘Crushing Fraud Chili Cook-Off Competition,’ an artificial intelligence initiative designed to enhance Medicare program integrity by detecting fraudulent billing activities in claims data. The competition solicits AI-powered solutions to analyze Medicare payment patterns, identify suspicious provider activities, and strengthen fraud detection capabilities across Medicare systems. This technology-driven approach aims to protect taxpayer funds and healthcare spending from fraudulent providers by leveraging advanced analytics to improve program oversight and payment integrity.
Source(s):
CMS ‘Chili Cookoff’ Challenge Solicits AI Solutions To Tackle Medicare Fraud (InsideHealthPolicy Daily News)
CMS Launches Crushing Fraud Chili Cook-Off Competition (CMS)
Tags: #PROVIDER, #PAYER, #HOSPITAL
Federal judge strikes down multiple CMS Medicare Advantage marketing and broker compensation regulations
A federal judge has vacated key CMS regulations governing Medicare Advantage operations, overturning both marketing rule provisions and broker compensation restrictions. The rulings grant health plans greater flexibility in marketing services to beneficiaries while removing limits on broker payments, potentially reshaping how Medicare Advantage plans communicate benefits and how brokers sell coverage. These decisions could significantly impact Medicare beneficiary access to plan information, insurance marketplace operations, and CMS oversight of the Medicare Advantage program.
Source(s):
Judge vacates Medicare Advantage marketing rule provisions (Fierce Healthcare)
Judge overturns rule limiting broker payments in Medicare Advantage (Healthcare Dive)
Tags: #PAYER, #PROVIDER
HHS and CMS Launch New Advisory Committee Initiative to Guide Healthcare Investment and Quality Improvement Policies
The Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) have established new advisory committees as part of a comprehensive initiative to enhance healthcare policy development. These committees will focus on expanding healthcare investment opportunities while improving patient care quality and health outcomes. The agencies are actively seeking nominations from healthcare providers, health systems, and patient advocacy groups to guide policy development on Medicare and Medicaid policies, healthcare provider reimbursement strategies, and investment frameworks that could significantly impact health systems, medical practices, and patient access to care services.
Source(s):
HHS and CMS Establish New Advisory Committees to Enhance Healthcare Investment Opportunities (AInvest)
HHS and CMS Call for Nominations for New Advisory Committee (Reuters)
Tags: #ALL
CMMI Proposal Would Let Specialists Offer $1,000 Annual Patient Incentives Under New Mandatory Payment Model
The Centers for Medicare & Medicaid Innovation (CMMI) has proposed a new mandatory Ambulatory Specialty Model enabling healthcare providers and specialists to offer Medicare beneficiaries up to $1,000 annually in non-cash patient incentives, including remote monitoring devices and fitness memberships. This CMS initiative targets improved care management and health outcomes for high-cost chronic conditions among Medicare patients, representing a shift in physician payment models and patient access strategies under federal healthcare policy.
Source(s):
CMMI Proposal Would Let Specialists Offer $1,000 Annual Patient Incentives Under New Mandatory Payment Model (InsideHealthPolicy Daily News)
Tags: #PROVIDER, #PATIENT, #PAYER
CMS To Guide States With Pending Work Requirement Waivers How To Navigate OBBB
The Centers for Medicare & Medicaid Services (CMS) is providing guidance to states with pending Medicaid work requirement waiver applications on navigating implications of new GOP legislation. The guidance clarifies how recent federal statutes affect existing and proposed state Medicaid policies, impacting patient access and insurance coverage for low-income beneficiaries across multiple states awaiting federal approval.
Source(s):
CMS To Guide States With Pending Work Requirement Waivers How To Navigate OBBB (InsideHealthPolicy Daily News)
Tags: #PATIENT, #PAYER, #PROVIDER
Healthcare coalition urges CMS to streamline access to medical devices
A coalition of healthcare stakeholders is urging the Centers for Medicare and Medicaid Services (CMS) to streamline medical device access and reimbursement processes, citing potential improvements to patient outcomes and reduced barriers for innovative device manufacturers seeking Medicare coverage for new technologies.
Source(s):
Healthcare coalition urges CMS to streamline access to medical devices (Medical Buyer)
Tags: #DEVICE, #PAYER, #PROVIDER
Medicare Part D Changes May Result in Increased Cost Sharing
A JAMA Health Forum study reveals that Medicare Part D prescription drug benefit changes, including new out-of-pocket cost caps, may paradoxically increase patient cost sharing for medications. The research highlights potential unintended consequences of CMS policy reforms on pharmaceutical access and Medicare beneficiary drug costs, raising concerns about patient access to prescription medications despite intended affordability improvements.
Source(s):
Medicare Part D Changes May Result in Increased Cost Sharing (Becker’s Hospital Review)
Tags: #DRUG, #PATIENT, #PAYER
CMS Inches Toward Establishing National Provider Directory
The Centers for Medicare & Medicaid Services (CMS) is advancing efforts to establish a comprehensive national healthcare provider directory to improve patient access to care and streamline provider information across Medicare and Medicaid programs. This initiative aims to address current fragmentation in provider data that affects patients seeking covered healthcare services.
Source(s):
CMS Inches Toward Establishing National Provider Directory (Modern Healthcare)
Tags: #PROVIDER, #PATIENT, #PAYER
MGMA Raises Concerns Over Medicare Physician Fee Schedule
The Medical Group Management Association (MGMA) has raised significant concerns about the 2026 Medicare Physician Fee Schedule proposed by CMS, warning of potential patient access crises due to Medicare reimbursement cuts. MGMA emphasizes these physician payment reductions would impact not only healthcare providers and medical practices but also threaten the broader healthcare workforce including nurses and administrative staff, ultimately affecting patient access to care and health outcomes across Medicare beneficiaries.
Source(s):
MGMA Raises Concerns Over Medicare Physician Fee Schedule (Health Exec)
Tags: #PROVIDER, #PATIENT, #PAYER
Food and Drug Administration (FDA)
FDA’s New Expert Panels Are Rife With Financial Conflicts and Fringe Views
The FDA’s increasing reliance on outside expert advisory panels has raised concerns about financial conflicts of interest and unconventional perspectives among panel members, potentially compromising the independence of FDA approval processes for pharmaceutical products and medical devices. These advisory committee integrity issues could impact public trust in FDA decision-making for medication approvals and patient access to treatments.
Source(s):
FDA’s New Expert Panels Are Rife With Financial Conflicts and Fringe Views (MedPageToday.com)
Tags: #DRUG, #DEVICE, #PATIENT
RFK Jr. Drives Sweeping FDA and Health Research Reforms Amid mRNA Vaccine Cancellations and Advisory Committee Overhaul
HHS Secretary Robert F. Kennedy Jr. is implementing major reforms across federal health agencies, including plans to eliminate conflicts of interest in FDA advisory committees and the Reagan-Udall Foundation while canceling mRNA vaccine research contracts. The sweeping changes target pharmaceutical oversight structures and research priorities, causing internal turmoil at HHS and raising concerns about regulatory independence. Additional reforms may include halting NIH gender data collection, potentially impacting health outcomes research, patient access to treatments, and evidence-based policy development affecting healthcare providers and insurance coverage decisions.
Source(s):
MAHA Report Hints At Changes To Reagan-Udall, FDA Ad Comms (InsideHealthPolicy Daily News)
Chaos After RFK Jr.’s mRNA Vaccine Decision; NIH Ending Gender Data Collection? (MedPageToday.com)
Tags: #ALL
FDA Adopts Staff Manual On ‘Gold Standard Science’ Policy
The FDA has implemented a new staff manual reflecting the Trump administration’s “Gold Standard Science” principles, emphasizing inclusion of alternative viewpoints in scientific deliberations. This FDA policy shift could significantly influence the agency’s regulatory approach to pharmaceutical approvals, medical device clearances, and public health guidance, potentially affecting drug pricing decisions and patient access to new treatments.
Source(s):
FDA Adopts Staff Manual On ‘Gold Standard Science’ Policy (InsideHealthPolicy Daily News)
Tags: #DRUG, #DEVICE, #PROVIDER
TAVR in patients with bicuspid aortic valve stenosis: Does device type matter?
The increasing preference for transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement for treating bicuspid aortic valve stenosis reflects advancements in medical device technology and cardiac care. The study examines whether different TAVR device types impact patient outcomes, with implications for FDA clearance standards, device manufacturer competition, Medicare payment policies, and patient access to minimally invasive cardiac interventions.
Source(s):
TAVR in patients with bicuspid aortic valve stenosis: Does device type matter? (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #PATIENT
Cardiovascular device approvals continue to lead the FDA’s Breakthrough Device Program
The FDA’s Breakthrough Device Program has designated 218 cardiovascular medical devices, representing the largest category for FDA clearance under this accelerated pathway. With 16 new device approvals in the past year, this regulatory support demonstrates continued innovation in cardiovascular care technology and potential improvements in patient access to advanced cardiac treatments for health systems and healthcare providers.
Source(s):
Cardiovascular device approvals continue to lead the FDA’s Breakthrough Device Program (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #HOSPITAL
FDA Suspends Valneva’s Chikungunya Vaccine License in the U.S.
The FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Ixchiq, Valneva’s chikungunya vaccine, halting pharmaceutical distribution for patients aged 60 and over. The FDA approval suspension affects patient access to the medication and represents a significant regulatory action impacting the vaccine manufacturer’s U.S. operations.
Source(s):
FDA Suspends Valneva’s Chikungunya Vaccine License in the U.S. (Reuters)
Tags: #DRUG, #PATIENT
FDA to Publish Daily Reports of Drug Adverse Events
The FDA will begin publishing daily adverse event reports for pharmaceutical products and biological medications, replacing quarterly updates to improve drug safety surveillance and public transparency. This policy shift by FDA Commissioner Marty Makary enhances the agency’s responsiveness to prescription drug safety concerns and streamlines reporting processes for healthcare providers and patients monitoring medication risks.
Source(s):
FDA to Publish Daily Reports of Drug Adverse Events (Stat)
Tags: #DRUG, #PROVIDER, #PATIENT
Health and Human Services
New Study Contradicts RFK Jr.’s Claims About Widespread Vaccine Panel Conflicts of Interest at CDC and FDA
A comprehensive JAMA study directly challenges HHS Secretary Robert F. Kennedy Jr.’s assertions that CDC and FDA vaccine advisory panels are ‘plagued’ by conflicts of interest, finding such conflicts at historically low levels. The analysis reveals only 5% financial conflicts among CDC’s Advisory Committee on Immunization Practices members and 0% among FDA vaccine panel members, contradicting claims of widespread pharmaceutical industry influence. The findings suggest significantly improved transparency in federal vaccine policy decision-making processes and reduced industry ties affecting key immunization recommendations and regulatory oversight, potentially influencing future advisory committee governance and vaccine safety discussions.
Source(s):
Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds (Stat)
Are Vaccine Panels at CDC, FDA ‘Plagued’ by Conflicts? Numbers Say No (MedPageToday.com)
Tags: #DRUG, #PROVIDER, #PATIENT
HHS Launches MAHA Interactive Platform to Track Trump Administration Health Policy Reforms
The Department of Health and Human Services has launched the “Make America Healthy Again in Action” interactive platform and dashboard to provide transparency and track healthcare policy reforms under Secretary Robert F. Kennedy Jr. and President Trump. The comprehensive platform monitors federal health initiatives including food safety regulations and vaccine advisory committee reforms while showcasing aligned state-level healthcare programs and policy reforms. The system offers stakeholders real-time updates on federal health policy implementation and regulatory changes affecting healthcare providers and public health programs, though specific program details and metrics were not disclosed in initial announcements.
Source(s):
HHS Launches Interactive Platform (Becker’s Hospital Review)
New HHS Dashboard Promotes States’ MAHA Policies (InsideHealthPolicy Daily News)
Tags: #ALL
Supreme Court Upholds Trump Administration’s $783 Million NIH Diversity Program Funding Cuts
The Supreme Court has cleared the way for the Trump administration to implement $783 million in cuts to National Institutes of Health diversity, equity, and inclusion programs, representing a significant reduction in federal biomedical research funding. The narrow Supreme Court decision affects academic medical centers, research institutions, and healthcare provider training programs nationwide. The cuts could impact patient access to clinical trials, culturally competent care, medical research outcomes across various disease areas, and therapeutic development programs. Legal challenges continue as the decision reshapes NIH grant policies, HHS research priorities, and federal health equity funding streams.
Source(s):
Supreme Court Allows $783 Million NIH Funding Cuts in Anti-DEI Efforts (Stat)
Supreme Court Narrowly OKs NIH Cuts (Becker’s Hospital Review)
Supreme Court Allows Trump Administration to Cut DEI Research at NIH (MedPageToday)
Tags: #ALL
HHS Secretary RFK Jr. Escalates Legal Warnings to Physicians Over CDC Vaccine Compliance
HHS Secretary Robert F. Kennedy Jr. has intensified warnings to healthcare providers about potential legal liability for deviating from CDC vaccine guidelines, specifically targeting pediatricians who follow American Academy of Pediatrics recommendations that conflict with federal guidance. The confrontation highlights escalating tensions between federal health policy, physician practice autonomy, and political influences on vaccination protocols. This creates significant legal uncertainty for medical practitioners regarding standard of care requirements, professional liability exposure, and patient access to preventive care, as doctors navigate conflicting guidance from professional medical organizations versus federal agencies.
Source(s):
RFK Jr. Claims AAP Vaccine Guidelines Threaten Liability For Doctors, Pharma-Driven (InsideHealthPolicy Daily News)
HHS Secretary Warns Doctors of Liability for CDC Noncompliance (MedPageToday.com)
Tags: #PROVIDER, #PATIENT, #ALL
340B Drug Pricing Program Faces New Oversight Challenges and Documentation Requirements
The 340B drug pricing program, which requires pharmaceutical companies to provide discounted medications to safety-net hospitals and healthcare providers since 1992, is experiencing heightened regulatory scrutiny. HRSA has proposed new documentation requirements for STD clinics participating in the program to verify eligibility for clinics receiving in-kind support, potentially affecting patient access to discounted medications at federally qualified health centers. These developments highlight ongoing challenges facing the program regarding oversight, patient access, and pharmaceutical industry compliance that continue to impact healthcare reimbursement and drug pricing policy across the safety-net provider landscape.
Source(s):
HRSA Proposes New Documentation Rules for 340B STD Clinics (InsideHealthPolicy Daily News)
The 340B Program: An Overview of Its Impact and Challenges (Becker’s Hospital Review)
Tags: #DRUG, #HOSPITAL, #PATIENT
Federal plan targets real-world data for health research: Report
The Department of Health and Human Services is developing a comprehensive strategy to modernize health research through real-world data integration, focusing on electronic health records and wearable device analytics to address chronic diseases and improve patient outcomes. The NIH-led initiative specifically targets medication overprescription issues in pediatric populations while enabling FDA post-approval pharmaceutical monitoring through real-world evidence. This policy shift could enhance care quality assessment and support more targeted healthcare provider interventions across health systems.
Source(s):
Federal plan targets real-world data for health research: Report (Becker’s Hospital Review)
Tags: #ALL
Calley Means, RFK Jr. Allege Pharma Behind MAGA-MAHA Conflict
HHS Secretary Robert F. Kennedy Jr. and advisor Calley Means dismiss allegations that pharmaceutical interests are driving tensions between MAGA and MAHA factions over health wearables policy. Both officials reaffirm their commitment to the Make America Healthy Again agenda, which targets public health reform, patient access improvements, and enhanced care quality through medical device innovation and healthcare provider engagement.
Source(s):
Calley Means, RFK Jr. Allege Pharma Behind MAGA-MAHA Conflict (InsideHealthPolicy Daily News)
Tags: #DEVICE, #PATIENT, #PROVIDER
After CDC Shooting, HHS Workers Call Out Kennedy’s ‘Dangerous’ Rhetoric
Following a CDC shooting incident, over 750 current and former HHS employees have demanded Secretary RFK Jr. stop spreading health misinformation that undermines public trust in federal health agencies including CDC and FDA. The unprecedented employee action highlights growing concerns about healthcare worker safety, agency morale, and potential impacts on public health policy implementation amid rising anti-government tensions affecting HHS operations.
Source(s):
After CDC Shooting, HHS Workers Call Out Kennedy’s ‘Dangerous’ Rhetoric (MedPageToday.com)
Tags: #ALL
A Closer Look at the $50 Billion Rural Health Fund in the New Reconciliation Law
The new reconciliation law establishes a $50 billion rural health fund to expand healthcare access in underserved communities, with significant implications for Medicare and Medicaid reimbursement, hospital systems, and patient access to care. This federal investment through HHS aims to reduce health disparities and strengthen rural healthcare infrastructure, potentially affecting physician practices, health outcomes, and insurance coverage in remote areas nationwide.
Source(s):
A Closer Look at the $50 Billion Rural Health Fund in the New Reconciliation Law (KFF)
Tags: #ALL
HHS Ends Union Recognition for Thousands of Workers
The Department of Health and Human Services has revoked collective bargaining rights for thousands of federal employees across major health agencies including the CDC, NIH, and FDA, potentially impacting healthcare policy implementation and regulatory oversight at these critical public health institutions.
Source(s):
HHS Ends Union Recognition for Thousands of Workers (Stat)
Tags: #ALL
Physician Groups Sue HHS Over Grant Removals
Two physician organizations have filed a lawsuit against HHS Secretary Robert F. Kennedy, Jr. challenging the cessation of research grants from the Agency for Healthcare Research and Quality (AHRQ). The healthcare providers cite concerns about patient safety, care quality, and health outcomes, arguing the grant removals could impact medical research and healthcare provider capabilities.
Source(s):
Physician Groups Sue HHS Over Grant Removals (Becker’s Hospital Review)
Tags: #PROVIDER, #PATIENT
AAP and ACOG Break with Federal Health Agencies on Pediatric COVID Vaccination
The American Academy of Pediatrics has issued independent COVID-19 vaccination recommendations that diverge from CDC and FDA guidance, advocating for shots for all children aged 6-23 months despite federal restrictions limiting access to older populations and high-risk groups. The American College of Obstetricians and Gynecologists (ACOG) has also diverged from CDC guidance by recommending COVID-19 vaccination during pregnancy as of August 22, 2025, creating potential conflicts for healthcare providers navigating federal versus professional society recommendations. This physician guidance aligns with ongoing endorsements for influenza and RSV vaccinations, indicating a proactive stance on maternal and fetal health outcomes amidst evolving vaccination protocols that may impact patient access to care and insurance coverage decisions.
Source(s):
National Pediatrics Group Splits with RFK Jr. on Covid Vaccinations (Stat)
Pediatrics group breaks with CDC on COVID vaccine guidance (Becker’s Hospital Review)
AAP’s New COVID Shot Recommendations Differ From CDC Advice (MedPageToday.com)
ACOG Recommends COVID-19 Vaccines for Pregnant Women (InsideHealthPolicy Daily News)
Tags: #PATIENT, #PROVIDER, #DRUG
Heard on the Hill
CBO report warns of nearly $500B in potential Medicare cuts
A Congressional Budget Office report warns that the Statutory Pay-As-You-Go Act could trigger $491 billion in Medicare cuts from 2027-2034 following passage of the One Big Beautiful Bill Act. Medicare payment reductions would be capped at 4% annually, resulting in approximately $45 billion in hospital reimbursement and provider payment cuts in 2026 alone. The CBO estimates a $415 billion sequestration in fiscal 2026, raising concerns about Medicare program sustainability and healthcare provider financial stability amid growing federal deficits.
Source(s):
CBO report warns of nearly $500B in potential Medicare cuts (Becker’s Hospital Review)
Tags: #HOSPITAL, #PROVIDER, #PAYER
Senate Labor-HHS Funding Bill a Rebuke to Trump’s Budget Proposal, Experts Say
The Senate Labor-HHS appropriations bill represents a significant departure from Trump administration budget proposals, potentially reshaping funding priorities for key health agencies including HHS, CDC, and FDA. This legislative shift could impact Medicare and Medicaid programs, hospital reimbursement rates, patient access to care, and overall healthcare provider funding allocations, signaling evolving federal health policy directions under current congressional leadership.
Source(s):
Senate Labor-HHS Funding Bill a Rebuke to Trump’s Budget Proposal, Experts Say (MedPageToday.com)
Tags: #ALL
GOP Doc Caucus Urges HHS To Overhaul USPSTF, Add Non-Biased Specialists
The Republican Doctor’s Caucus is urging HHS to reform the United States Preventive Services Task Force (USPSTF), calling for non-biased clinical specialists and greater transparency in preventive care coverage recommendations. The push targets insurance coverage decisions for preventive services, aiming to ensure science-based health guidance that impacts patient access to screening and preventive care under Medicare and health plans.
Source(s):
GOP Doc Caucus Urges HHS To Overhaul USPSTF, Add Non-Biased Specialists (InsideHealthPolicy Daily News)
Tags: #PROVIDER, #PATIENT, #PAYER
Cigna’s Downcoding Policy Criticized as Unlawful by Lawmakers
Representative Greg Murphy and the California Medical Association have condemned Cigna’s new policy that automatically downcodes certain medical procedures, calling it unlawful. The payer policy change affects physician reimbursement rates and healthcare provider revenue, raising concerns about insurance coverage practices and potential impacts on patient access to care.
Source(s):
Cigna’s Downcoding Policy Criticized as Unlawful by Lawmakers (InsideHealthPolicy Daily News)
Tags: #PROVIDER, #PAYER, #PATIENT
Notable Notes
AMA Issues AI Guidance for Health Systems
The American Medical Association (AMA) released “Governance for Augmented Intelligence,” an eight-step policy framework to help health systems and healthcare providers implement AI governance, accountability measures, and physician training protocols. With nearly 70% of physicians using AI tools in 2024, the toolkit addresses growing integration of artificial intelligence in medical practice and patient care delivery across hospital systems.
Source(s):
AMA Issues AI Guidance for Health Systems (Becker’s Hospital Review)
Tags: #PROVIDER, #HOSPITAL
Pharma Looks To Appease Trump With DTC Sales, But Sidesteps MFN Pricing
Pharmaceutical companies are pursuing direct-to-consumer drug sales strategies to align with President Trump’s healthcare agenda while resisting his “most favored nation” prescription drug pricing policies. Industry analysts suggest this selective compliance approach may yield a political compromise, though current DTC sales models are unlikely to deliver meaningful drug pricing relief or improve patient access to affordable medications. The pharmaceutical industry’s response highlights ongoing tensions over Medicare drug pricing reform and regulatory approaches to controlling prescription medication costs.
Source(s):
Pharma Looks To Appease Trump With DTC Sales, But Sidesteps MFN Pricing (InsideHealthPolicy Daily News)
Tags: #DRUG, #PATIENT, #PAYER
How health systems are bracing for tariffs
Health systems are implementing supply chain risk management strategies and increasing monitoring of critical medical device and pharmaceutical inventory as they prepare for potential tariffs on healthcare imports under the Trump administration. Hospital reimbursement models may face pressure as procurement costs rise, potentially affecting patient access to essential medical supplies and prescription medications.
Source(s):
How health systems are bracing for tariffs (Becker’s Hospital Review)
Tags: #ALL
Gilead Slammed For Impeding Global Access To Long-Acting PrEP
Advocacy groups are pressuring Gilead Sciences to accelerate pharmaceutical registration of its long-acting HIV pre-exposure prophylaxis medication in low-income countries, highlighting critical concerns about drug pricing, patient access, and global health equity disparities that could impact HIV prevention programs worldwide.
Source(s):
Gilead Slammed For Impeding Global Access To Long-Acting PrEP (InsideHealthPolicy Daily News)
Tags: #DRUG, #PATIENT
What updated thresholds for statin use could mean for patients
A new model for estimating atherosclerotic cardiovascular disease risk, released in November 2023, may result in 40% of U.S. adults no longer qualifying for statin prescriptions used to manage cholesterol. This pharmaceutical policy change could significantly impact Medicare reimbursement, insurance coverage, and patient access to these widely prescribed medications, affecting healthcare providers’ prescribing practices and health outcomes for cardiovascular disease management.
Source(s):
What updated thresholds for statin use could mean for patients (Stat)
Tags: #DRUG, #PROVIDER, #PAYER
FTC challenge to Edwards JenaValve acquisition could delay FDA approval
Edwards Lifesciences faces an FTC antitrust challenge to its JenaValve acquisition that could delay FDA approval of the Trilogy heart valve, illustrating how federal regulatory oversight of medical device manufacturer consolidation can impact device approval timelines and potentially affect patient access to new cardiac technologies.
Source(s):
FTC challenge to Edwards JenaValve acquisition could delay FDA approval (Cardiovascular Business)
Tags: #DEVICE, #PATIENT
OPM will forego FEVS in 2025, despite law requiring it
The Office of Personnel Management will skip the legally-required 2025 Federal Employee Viewpoint Survey, raising compliance concerns about mandated federal workforce assessment. The cancellation appears aimed at refocusing survey priorities while removing diversity-related questions, potentially impacting federal healthcare agencies including HHS, CDC, and FDA employee engagement monitoring.
Source(s):
OPM will forego FEVS in 2025, despite law requiring it (Government Executive)
Tags: #PROVIDER, #HOSPITAL