Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
340B Drug Discount Program Faces Industry Upheaval as Bausch Health Exits While HRSA Pilots Rebate System
The 340B drug discount program is experiencing significant structural changes as Bausch Health announced its exit from Medicaid and 340B programs effective October 1, 2025, citing pricing pressures from federal policy changes. Simultaneously, HRSA is launching a controversial rebate pilot program January 1, 2026, with eight drugmakers that shifts from upfront discounts to post-sale rebates, despite bipartisan opposition and hospital stakeholder warnings of increased administrative costs. These concurrent developments signal broader industry resistance to government drug pricing initiatives and raise concerns about medication access for vulnerable Medicare and Medicaid patients served by safety-net providers, while CMS oversight implications for both changes remain unclear.
Source(s): STAT, Becker’s Hospital Review
Tags: #ALL
Healthcare providers face mixed CMS payment outlook as Medicare reimbursement increases clash with surgical cuts and broader financial pressures
CMS announced a 3.26% physician reimbursement increase for 2026 emphasizing chronic disease management, while simultaneously finalizing a 2.5% cut to surgical and outpatient procedure payments to rebalance specialist versus primary care compensation. These modest Medicare adjustments fall short of addressing the broader financial crisis facing providers, as Kaufman Hall data shows physician reimbursement dropped 7% from Q2 2023 to Q2 2025 while expenses rose 7%. Major health systems including HCA Healthcare and Community Health Systems are simultaneously preparing for potential losses up to $100 million annually if enhanced ACA subsidies expire, creating compounded financial pressures that could force service cuts particularly impacting rural and underserved populations.
Source(s): Health Exec, Stat, modernhealthcare.com, Becker’s Hospital Review
Tags: #PROVIDER, #HOSPITAL, #PAYER
Former Unite Us CEO Appointed to Lead Medicaid and CHIP at CMS
Dan Brillman, former Unite Us CEO with coordinated care expertise, appointed to lead Medicaid and CHIP programs at CMS. His background in care coordination technology may influence federal safety net policies, potentially impacting hospitals, Medicare integration, and pharmaceutical access for vulnerable populations served by these programs.
Source(s): Health Exec
Tags: #ALL
Biden’s law sets Trump up for success in negotiating cheaper Medicare drug prices
The Trump administration will announce Medicare drug-price negotiation results for high-demand pharmaceuticals including semaglutide, potentially achieving greater CMS savings than Biden’s initial rounds.
Source(s): Stat
Tags: #DRUG, #PAYER, #PATIENT
Democrats press CMS over Medicare provider list errors
Democrats are urging the Centers for Medicare & Medicaid Services (CMS) to address inaccuracies in the Medicare provider directory that could disrupt beneficiaries’ access to hospitals and healthcare services. The data reliability issues raise concerns about patient care coordination and provider network transparency, potentially affecting Medicare reimbursements and healthcare delivery across the system.
Source(s): Modern Healthcare News
Tags: #PAYER, #HOSPITAL, #PATIENT
States reject Dr. Oz’s claims of Medicaid spending on undocumented immigrants
CMS Administrator Mehmet Oz’s disputed $1 billion Medicaid claim regarding undocumented immigrants sparked state pushback and highlighted federal-state tensions over healthcare eligibility verification.
Source(s): Stat
Tags: #PAYER, #HOSPITAL, #PROVIDER
Food and Drug Administration (FDA)
FDA Drug Division Leadership Crisis Deepens as Chief’s Resignation Triggers Industry Lawsuit and Regulatory Uncertainty
Dr. George Tidmarsh’s resignation as head of the FDA’s Center for Drug Evaluation and Research amid misconduct allegations has created a leadership vacuum that threatens to disrupt pharmaceutical approval processes and regulatory oversight. Aurinia Pharmaceuticals has filed suit against Tidmarsh, claiming his regulatory decisions caused substantial financial losses, highlighting growing tensions between FDA oversight responsibilities and industry relationships. The departure creates uncertainty for drug approvals, Medicare coverage decisions, and hospital formulary planning during a critical period of regulatory reviews, potentially compromising regulatory integrity across pharmaceutical and device sectors.
Source(s): MedPageToday.com, STAT, nytimes.com
Tags: #DRUG, #HOSPITAL, #PAYER
Long-Term Outcomes of TAVR Approach Surgical Replacement
Recent findings suggest that long-term outcomes for patients undergoing transcatheter aortic valve replacement (TAVR) are increasingly comparable to those of traditional surgical aortic valve replacement (SAVR). This emerging data may influence clinical decision-making and FDA device approval criteria for low-risk patients requiring valve replacement. The comparable outcomes could impact Medicare coverage decisions and hospital procedural volume allocation, as TAVR’s less invasive approach may reduce healthcare costs while maintaining clinical effectiveness for broader patient populations.
Source(s): MedPageToday.com
Tags: #ALL
Chair of Controversial Vaccine Panel Emphasizes Commitment to Science
In a recent interview, Martin Kulldorff, chair of a controversial FDA vaccine advisory panel, stated that he has been instructed by the health secretary to impartially follow scientific evidence in his work. This statement comes amid ongoing debates regarding pharmaceutical vaccine policies and the role of science in public health decision-making.
Source(s): POLITICO
Tags: #ALL
Patient sues Abbott after early heart valve replacement
A patient sued Abbott for “permanent injuries” from premature Trifecta GT heart valve failure after six years, highlighting FDA device safety oversight gaps. Abbott withdrew the valve from U.S. markets in 2023 due to structural deterioration risks, raising questions about Medicare coverage for replacement procedures and patient protection protocols.
Source(s): Cardiovascular Business
Tags: #DEVICE, #PATIENT, #PAYER
Sapien M3 TMVR Easily Beats Expectations in Pivotal Trial
In a pivotal trial, the FDA-tracked Sapien M3 device demonstrated exceptional one-year outcomes for patients with mitral regurgitation undergoing transcatheter mitral valve replacement (TMVR). This promising data could influence Medicare coverage decisions and hospital adoption, potentially transforming treatment options in challenging cardiac care where device innovation significantly impacts patient outcomes and healthcare policy.
Source(s): MedPageToday.com – medical news for physicians
Tags: #DEVICE, #PROVIDER, #PAYER
Evoque TTVR system linked to favorable outcomes in new real-world analysis
A new TCT 2025 analysis of over 1,000 real-world patients demonstrates the FDA-approved Evoque transcatheter tricuspid valve replacement system’s favorable safety and efficacy outcomes. This medical device data could influence CMS Medicare coverage decisions and hospital adoption strategies for treating tricuspid valve disease, potentially impacting cardiovascular care access and reimbursement policies.
Source(s): Cardiovascular Business
Tags: #ALL
FDA Launches Effort to Ease Approval Pathway for Biosimilars
The FDA has launched new guidance to streamline biosimilar approvals, potentially reducing pharmaceutical costs for Medicare patients with autoimmune diseases and cancer. This FDA policy initiative aims to increase market competition, benefiting hospitals and healthcare providers while improving patient access to affordable biologics through simplified regulatory pathways.
Source(s): MedPageToday.com – medical news for physicians
Tags: #ALL
What can Healthcare Manufacturing Learn from FDA’s ANDA Prioritization Pilot?
The FDA’s ANDA Prioritization Pilot enhances domestic pharmaceutical manufacturing and supply chain resilience by accelerating generic drug approvals for U.S.-based facilities. This FDA initiative addresses pandemic-exposed vulnerabilities, reduces foreign dependency, and impacts Medicare costs through improved generic access, with stakeholder benefits expected within 5-10 years.
Source(s): pharmexec.com
Tags: #DRUG, #PAYER
Health and Human Services
SAMHSA Workforce and Funding Slashed by Half Amid National Mental Health Crisis
The Substance Abuse and Mental Health Services Administration (SAMHSA) has experienced workforce cuts exceeding 50% alongside the termination of between $1.7-2 billion in block grants and $350 million in addiction prevention funding cuts initiated during the Trump administration. These dramatic reductions have left the agency severely weakened during a national drug overdose epidemic and rising suicide rates, with remaining staff demoralized and the agency’s capacity to coordinate with CMS on Medicare mental health coverage and support pharmaceutical addiction treatment programs now in jeopardy. Local governments, hospitals, and mental health advocates have raised significant concerns about SAMHSA’s diminished ability to respond effectively to ongoing public health crises.
Source(s): Stat, Stat
Tags: #ALL
Trump’s Administration Implements Loyalty-Based Performance Reviews for HHS Employees
The Trump administration has introduced a new performance review criterion for Department of Health and Human Services (HHS) employees, requiring them to demonstrate loyalty to the President’s policy agenda. This change, which affects tens of thousands of employees, raises concerns about politicizing the civil service and undermining the agency’s independence, particularly in the Office of the Inspector General. The new requirement has been interpreted by some employees as a threat to job security during a time of government shutdown and workforce cuts.
Source(s): huffpost.com
Tags: #ALL
NIH Funding Controversy Leads to Changes in Grant Titles
Researchers at Vanderbilt faced NIH pressure to alter grant titles to secure federal funding, reflecting political interference in health disparities research. The controversy over Tennessee’s rejection of HIV prevention funds highlights how Medicare and public health policies are influenced by political considerations.
Source(s): Stat
Tags: #ALL
Senate hearing for Casey Means, Trump’s surgeon general pick, is postponed after she goes into labor
The Senate confirmation hearing for Dr. Casey Means, President Trump’s surgeon general nominee, has been postponed due to her going into labor. This delay affects the timeline for key healthcare policy leadership, potentially impacting FDA oversight, Medicare programs, and hospital system guidance during the administration transition. Rescheduling remains uncertain.
Source(s): Stat
Tags: #ALL
HHS Nixes Another USPSTF Meeting
The Department of Health and Human Services has canceled another meeting of the U.S. Preventive Services Task Force (USPSTF), originally scheduled for November. This cancellation raises concerns about the continuity of preventive health guidelines and the agency’s ability to fulfill its essential functions.
Source(s): MedPageToday.com
Tags: #PROVIDER, #PATIENT, #PAYER
Heard on the Hill
Federal Court Rulings Preserve Healthcare Agency Operations as Government Shutdown Threatens $14 Billion Economic Loss
Federal judges have blocked Trump administration attempts to execute mass layoffs of 4,000 federal employees during the ongoing five-week government shutdown, protecting critical healthcare oversight at FDA and CMS amid Medicare open enrollment. The Congressional Budget Office estimates the shutdown will permanently cost the economy at least $7 billion, potentially reaching $14 billion, as disruptions affect pharmaceutical approvals, medical device reviews, Medicare services, and hospital compliance monitoring. Federal employee unions led by the American Federation of Government Employees continue pressuring Congress for resolution while healthcare stakeholders face mounting concerns over staffing shortages that could impact beneficiary access to care and coverage determinations.
Source(s): Government Executive, Government Executive – All Content, Government Executive, The Hill, POLITICO
Tags: #ALL
ACA Marketplace Premiums Show Sharp Contrast as Some Plans Drop to $50 While Others See Major Increases
The Centers for Medicare & Medicaid Services has highlighted Affordable Care Act marketplace premiums as low as $50 to boost enrollment, even as newly released government data reveals significant premium increases across many plans for the upcoming year. This pricing disparity emerges amid congressional struggles to agree on ACA subsidies, creating uncertainty for consumers navigating coverage options. The contrasting premium trends reflect ongoing challenges in healthcare affordability and accessibility, with implications for enrollment rates and coverage reach across different market segments.
Source(s): The New York Times, The Hill
Tags: #PAYER, #PATIENT
Democratic Senators Demand Transparency in Tariff Processes
A coalition of Democratic senators is pressing Commerce Secretary Howard Lutnick for increased transparency regarding the administration’s use of national security statutes to impose tariffs on pharmaceutical and medical device sectors. They argue these measures have strayed from their intended purpose and are demanding reevaluation of their implications on public health, hospital costs, and patient access to FDA-approved treatments and Medicare-covered devices.
Source(s): InsideHealthPolicy Daily News
Tags: #ALL
Advocates Hopeful Price Transparency Can Be Bipartisan Priority Once APTC Standoff Ends
Consumer advocates are optimistic about bipartisan healthcare price transparency legislation being included in year-end packages once Congress resolves the APTC standoff. The policy would enhance patient cost awareness across hospital and pharmaceutical services, potentially impacting Medicare beneficiaries and requiring CMS oversight of transparency requirements for healthcare providers and device manufacturers.
Source(s): InsideHealthPolicy Daily News
Tags: #ALL
Notable Notes
Healthcare Consolidation Accelerates as Private Equity and Corporate Giants Reshape Provider Markets Amid Medicare Reimbursement Changes
A wave of healthcare consolidation is transforming provider markets as UnitedHealth Group shifts toward directly employing its 90,000 clinicians, Cardinal Health completes a $1.9 billion acquisition of 750 physicians through Solaris Health, and private equity firms acquire 340 outpatient cardiology practices over the past decade driven by increased Medicare reimbursement for ambulatory procedures. These consolidation trends raise significant concerns about patient care quality and costs, with new research in Annals of Internal Medicine showing private equity hospital acquisitions negatively impact staffing and patient outcomes. The rapid consolidation across multiple healthcare sectors is prompting calls for stronger CMS oversight and regulatory scrutiny as traditional boundaries between payers, providers, and pharmaceutical companies blur in pursuit of vertical integration and profit maximization.
Source(s): STAT, modernhealthcare.com, modernhealthcare.com, MedPageToday.com
Tags: #PAYER, #PROVIDER, #PATIENT
Political Health Movements Challenge FDA Authority on Food and Drug Policy
The Make America Healthy Again (MAHA) movement, led by HHS Secretary Robert F. Kennedy Jr., is pushing for FDA-supported analysis of statin efficacy through an October 21 roundtable initiative, potentially affecting Medicare coverage for millions of beneficiaries and impacting cardiovascular treatment markets. This pharmaceutical policy scrutiny reflects a broader politicization of health and wellness issues in America, as seen in how retailers like Whole Foods must navigate increasingly political discussions around diet and FDA food regulations. The movement’s influence spans from questioning established drug therapies to challenging food policy, creating policy uncertainty for healthcare providers, hospitals, device manufacturers, and retailers operating in the wellness sector.
Source(s): The New York Times, InsideHealthPolicy Daily News
Tags: #PATIENT, #PAYER
White House Accelerates Deregulation Efforts
The Trump administration has directed federal agencies to expedite regulatory repeals, bypassing standard public comment procedures through a 14-day review process for “facially unlawful” rules. This deregulation push could significantly impact FDA pharmaceutical and medical device oversight, CMS Medicare policies, and hospital safety regulations, raising concerns among healthcare advocacy groups about potential risks to patient protection and care quality standards.
Source(s): Government Executive
Tags: #ALL
Scholarship in Healthcare Quality & Safety Has Come a Long Way
The field of healthcare quality and safety (HQS) has evolved significantly since 2008, gaining recognition among healthcare professionals and regulatory stakeholders. This growth reflects increased CMS and FDA oversight, Medicare quality reporting requirements.
Source(s): MedPageToday.com – medical news for physicians
Tags: #ALL
AI for medical coding is helping this primary care clinic open a dozen more locations
Med First, a primary and urgent care chain in North and South Carolina, implemented AI medical coding technology, generating 6% revenue increases per visit. This efficiency gain enables expansion from 27 to 40 locations, improving healthcare access in underserved rural communities while potentially influencing CMS reimbursement optimization strategies for similar provider networks.
Source(s): STAT
Tags: #PROVIDER, #HOSPITAL
The big flaw in Big Pharma’s ‘patient advocacy’
Pharmaceutical companies invest millions in patient advocacy programs, yet much of this funding supports superficial public relations initiatives rather than meaningful assistance for patients with rare diseases. Industry efforts often lack tangible outcomes, raising questions about FDA oversight and Medicare coverage gaps that leave vulnerable patient populations underserved despite corporate advocacy claims.
Source(s): STAT
Tags: #DRUG, #PATIENT, #PAYER
What’s on tap at a major heart conference
The American Heart Association’s upcoming scientific sessions in New Orleans will present research on cardiovascular disease, including studies linking heart failure to chronic kidney disease and exploring disparities in heart attack outcomes. This conference will gather a diverse group of stakeholders, including physicians, researchers, and patient advocates, to discuss advancements in heart health.
Source(s): STAT
Tags: #PROVIDER, #DEVICE, #DRUG
Here’s What Happens to Your Body When Clocks ‘Fall Back’ an Hour
As daylight saving time ends, individuals are encouraged to enjoy an extra hour of sleep while getting morning sunlight to reset body clocks. Healthcare providers should advise patients on circadian rhythm management, as sleep disruptions can affect medication timing and patient outcomes.
Source(s): MedPage Today Primary Care
Tags: #PROVIDER, #PATIENT