Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Trump’s Proposal to Redirect ACA Subsidies Directly to Consumers Sparks Warnings of Marketplace Collapse
President Trump has proposed redirecting federal ACA subsidies directly to consumers instead of insurers, with subsidies expiring during the current government shutdown leaving millions facing premium increases. Policy experts warn the plan could destabilize ACA marketplaces and undermine existing Medicare frameworks, threatening coverage for millions while disrupting hospital reimbursements and pharmaceutical access. CMS is evaluating implementation challenges for Medicare-eligible populations as healthcare providers navigate mounting reimbursement uncertainties under the proposed policy shift.
Source(s):
Trump floats sending ACA dollars directly to consumers (Becker’s Hospital Review)
Obamacare could collapse under Trump’s new plan, policy experts say (POLITICO)
Tags: #ALL
CMS Prior Authorization Reforms Create Implementation Challenges Across Medicare Systems
The Centers for Medicare & Medicaid Services is implementing sweeping prior authorization changes through the CMS-0057-F interoperability requirements and the Trump administration’s WISeR model, mandating automated approval processes and extending prior authorizations to traditional Medicare for the first time. While these reforms aim to reduce unnecessary healthcare spending and improve data sharing between hospitals, pharmacies, and Medicare systems, patients continue facing medication access barriers despite electronic prescribing improvements, prompting bipartisan congressional opposition from eight Democratic senators. Healthcare payers, pharmaceutical companies, medical device manufacturers, and vulnerable populations relying on government healthcare programs are navigating this regulatory transformation that breaks down clinical data silos while potentially creating new care delivery obstacles.
Source(s):
Patients Encounter Barriers Despite Prescription Approvals (MedPageToday.com – medical news for physicians)
Maximizing Your ROI While Meeting CMS Interoperability and Prior Authorization Requirements (Fierce Healthcare)
CMS’ AI program to add prior authorizations to traditional Medicare; new bill aims to stop it (Health Exec)
Tags: #ALL
The Trump administration’s drug pricing deals, explained
In late 2025, the Trump administration announced significant agreements with major pharmaceutical companies, including Pfizer and AstraZeneca, to implement a “most-favored-nation” pricing model for drugs, aligning U.S. prices with those in other wealthy nations. Pfizer’s deal, announced in September, involves a $70-$90 billion investment in domestic manufacturing and offers Medicaid patients discounts of up to 100%. Notably, Eli Lilly and Novo Nordisk will provide GLP-1 drugs at capped prices starting in 2026, potentially lowering costs for Medicare beneficiaries and Medicaid patients significantly. The success of these initiatives will depend on the effective rollout of the TrumpRx platform, set to launch in 2026.
Source(s):
The Trump administration’s drug pricing deals, explained (Becker’s Hospital Review)
Tags: #ALL
CMMI to launch model to lower Medicaid drug spending
The Center for Medicare and Medicaid Innovation (CMMI) announced plans to implement a new model aimed at reducing Medicaid drug spending, although specific details regarding the model’s structure and expected outcomes have yet to be disclosed. This initiative is part of broader efforts to control pharmaceutical costs within the Medicaid program, which could significantly impact state budgets and patient access to necessary medications. Stakeholders are awaiting further guidance on how this model will be operationalized and its implications for both providers and beneficiaries.
Source(s):
CMMI to launch model to lower Medicaid drug spending (Healthcare Dive)
Tags: #DRUG, #PAYER, #PATIENT
Lobbyists: CMS Telehealth Guidance Needed With CR Deal
Healthcare lobbyists are urging CMS to provide official guidance clarifying that retroactive Medicare payment for telehealth services will be recognized as established policy. This clarification is critical for hospitals and healthcare providers navigating post-pandemic telehealth reimbursement uncertainties. Stakeholders seek stable Medicare telehealth payment frameworks to ensure continued access to remote care services, as current policy ambiguity creates operational and financial planning challenges for healthcare systems relying on telehealth delivery models.
Source(s):
Lobbyists: CMS Telehealth Guidance Needed With CR Deal (InsideHealthPolicy Daily News)
Tags: #HOSPITAL, #PROVIDER, #PAYER
CMS Chief Criticized Over Medicaid Funding Claims
The Chief of the Centers for Medicare & Medicaid Services (CMS) faces criticism over Medicaid funding claims, as proposed cuts could reduce coverage access for vulnerable populations. Critics warn reductions may impact hospital reimbursements and pharmaceutical access, intensifying debates over Medicaid sustainability and its effects on healthcare providers and beneficiaries.
Source(s):
CMS Chief Criticized Over Medicaid Funding Claims (Medical Buyer)
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SCAI fighting for interventional cardiologists amid challenging payment policies
The Society for Cardiovascular Angiography and Interventions (SCAI) is advocating for interventional cardiologists facing declining Medicare reimbursements from CMS policy changes. The organization is partnering with medical societies to influence health policy affecting hospital-based cardiology services, device procedures, and physician compensation structures.
Source(s):
SCAI fighting for interventional cardiologists amid challenging payment policies (Cardiovascular Business)
Tags: #PROVIDER, #HOSPITAL, #PAYER
Medicare’s Big Opportunity: Paying for Prevention
The 2026 Medicare physician fee schedule proposes shifting CMS payment structures towards preventive care for chronic diseases, potentially reducing pharmaceutical and hospital costs while improving patient outcomes. This regulatory change could significantly impact healthcare providers, device manufacturers, and Medicare beneficiaries by incentivizing prevention over treatment-based care models.
Source(s):
Medicare’s Big Opportunity: Paying for Prevention (MedPageToday.com)
Tags: #ALL
The Orthopedic Outpatient Wave Isn’t Slowing Down
As CMS removes procedures from its Inpatient Only List, orthopedic surgeries shift to outpatient settings. Medicare reimbursement changes drive hospitals and ASCs to perform more joint replacements outpatient, improving efficiency while impacting hospital revenues and device manufacturer strategies for ambulatory markets.
Source(s):
The Orthopedic Outpatient Wave Isn’t Slowing Down (Becker’s Hospital Review)
Tags: #HOSPITAL, #DEVICE, #PROVIDER
CMS Advances Interoperability Initiative, Showcases Early Look at National Provider Directory
The Centers for Medicare & Medicaid Services (CMS) has advanced its healthcare interoperability initiative, unveiling an early national provider directory to improve care coordination across hospitals and healthcare systems. This Medicare-focused policy development aims to streamline patient access to services and enhance information exchange between providers, potentially impacting pharmaceutical and device companies’ care delivery partnerships. The initiative represents CMS’s broader effort to modernize healthcare data infrastructure and reduce administrative burdens for stakeholders.
Source(s):
CMS Advances Interoperability Initiative, Showcases Early Look at National Provider Directory (Fierce Healthcare)
Tags: #ALL
How much damage did the federal shutdown do to telehealth?
Following the federal shutdown, Medicare-covered telehealth services declined 24%, impacting older Americans’ healthcare access. The disruption affected CMS oversight of telehealth reimbursement policies, highlighting vulnerabilities in remote care delivery systems and potential long-term consequences for Medicare beneficiaries and healthcare providers relying on digital health services.
Source(s):
How much damage did the federal shutdown do to telehealth? (Stat)
Tags: #ALL
Food and Drug Administration (FDA)
FDA Names Richard Pazdur as New Drug Center Director Following Tidmarsh Resignation
The FDA appointed Richard Pazdur, MD, a 26-year agency veteran and longtime oncology regulator, as director of the Center for Drug Evaluation and Research (CDER) following George Tidmarsh’s resignation. The leadership change comes at a critical time for pharmaceutical regulation and is expected to significantly influence drug approval processes, Medicare coverage decisions, and hospital access to new therapies. Key stakeholders including the pharmaceutical industry, hospitals, and Medicare beneficiaries will be impacted as Pazdur brings his extensive oncology and regulatory innovation background to lead CDER during ongoing challenges in drug safety and efficacy oversight.
Source(s):
Richard Pazdur, longtime cancer regulator, named drug center director at FDA (Stat)
Richard Pazdur Appointed as Director of FDA’s Drug Center (MedPageToday.com – medical news for physicians)
FDA announces agency veteran will become top drug regulator after Tidmarsh resignation (The Hill)
Tags: #ALL
FDA Launches ‘Plausible Mechanism Pathway’ to Expedite Personalized Gene Therapy Approvals for Ultra-Rare Diseases
The FDA has introduced a new regulatory framework called the ‘plausible mechanism pathway’ that allows pharmaceutical companies to gain expedited approval for personalized gene therapies targeting ultra-rare diseases by demonstrating clinical improvement through biological mechanisms rather than traditional clinical trials, with emphasis on post-approval real-world data collection. This policy shift is expected to reduce drug development costs for manufacturers while potentially improving Medicare coverage pathways and streamlining CMS reimbursement processes for innovative treatments. The new framework will significantly impact hospitals’ access to cutting-edge therapies and could reduce coverage barriers for patients with unmet medical needs in specialized care areas.
Source(s):
FDA opens new approval route for personalized treatments (Becker’s Hospital Review)
US FDA unveils new pathway to approve personalized therapies (Reuters)
FDA ‘Plausible Mechanism’ Pathway To Speed Personalized Gene Therapies For Rare Diseases (InsideHealthPolicy Daily News)
Tags: #DRUG, #PATIENT
Spending Package Includes FDA Funding Without CDER, CBER Cuts
The Senate’s appropriations bill allocates $3.4 billion in FDA discretionary funding, preserving full budgets for CDER and CBER without cuts. This bipartisan decision ensures continued pharmaceutical and medical device regulatory oversight, maintaining drug approval processes critical for Medicare beneficiaries and hospital systems. The funding protects FDA’s public health mission while CMS and healthcare stakeholders benefit from sustained regulatory capacity during budget negotiations.
Source(s):
Spending Package Includes FDA Funding Without CDER, CBER Cuts (InsideHealthPolicy Daily News)
Tags: #ALL
FDA Officials Propose Changes to Vaccine Regulations
At a closed FDA meeting, officials including Tracy Beth Høeg proposed altering COVID-19 vaccine labeling to indicate risks outweigh benefits for males aged 12-24 due to myocarditis concerns. This pharmaceutical regulatory shift could impact healthcare access, provider recommendations, and public health policy, potentially creating barriers for this demographic while signaling evolving FDA vaccine oversight approaches.
Source(s):
FDA Officials Propose Changes to Vaccine Regulations (Stat)
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FDA unveils drugs to receive expedited review in support of ‘national priorities’
The FDA has announced a new initiative to expedite the review process for drugs that align with national health priorities. This strategy aims to enhance access to critical medications and streamline the regulatory process, reflecting an ongoing commitment to address public health needs.
Source(s):
FDA unveils drugs to receive expedited review in support of ‘national priorities’ (The Hill)
Tags: #DRUG, #PATIENT, #PROVIDER
FDA clears new cloud enabled Philips cardiovascular IT system
The FDA has approved Philips’ new cloud-enabled cardiovascular IT system for hospitals, enhancing workflows and analytics in cardiovascular care. This medical device approval establishes infrastructure for future AI-enabled tools, potentially improving patient outcomes and healthcare efficiency while supporting CMS quality initiatives through advanced data management capabilities.
Source(s):
FDA clears new cloud enabled Philips cardiovascular IT system (Cardiovascular Business)
Tags: #DEVICE, #HOSPITAL, #PROVIDER
FDA clears ultrasonic surgical aspiration tech for cardiac surgery
The FDA has approved Integra LifeSciences’ ultrasonic surgical aspiration device for cardiac surgery, expanding beyond its current neurosurgery and orthopedic applications. This FDA device clearance may impact hospital procurement decisions and Medicare reimbursement considerations for cardiac procedures, potentially improving surgical outcomes and healthcare delivery efficiency for cardiac patients.
Source(s):
FDA clears ultrasonic surgical aspiration tech for cardiac surgery (Cardiovascular Business)
Tags: #DEVICE, #HOSPITAL, #PROVIDER
The Era of Safe Bets in Psychiatric Medicine is Over
The pharmaceutical industry is shifting from conservative approaches to high-risk investments in novel psychiatric therapies, driven by FDA regulatory changes and unmet patient needs. This transformation could impact Medicare reimbursement policies, hospital treatment protocols, and CMS coverage decisions, while creating new financial opportunities for pharmaceutical companies and potentially improving patient outcomes through innovative mental health treatments.
Source(s):
The Era of Safe Bets in Psychiatric Medicine is Over (Stat)
Tags: #ALL
Health and Human Services
MAHA Summit Signals Major Shift in Federal Health Policy as Vance Endorses RFK Jr.’s Alternative Healthcare Agenda
The November 11, 2025 MAHA Summit brought together Health Secretary Robert F. Kennedy Jr., Vice President JD Vance, and FDA officials in a closed-door event that signaled potential regulatory shifts toward alternative healthcare approaches including psychedelics and food-as-medicine strategies. The secretive gathering of wellness influencers, political operatives, and healthcare stakeholders raised transparency concerns about industry influence on Medicare policy and CMS oversight, while suggesting upcoming changes to pharmaceutical regulations and medical device standards. This populist health coalition’s ascendance could significantly impact traditional healthcare industry lobbying dynamics and reshape administrative health policy implementation across FDA, CMS, and hospital systems.
Source(s):
Secretive MAHA Summit to Address Key Health Issues (Stat)
Who’s coming to the ‘hush-hush’ MAHA summit (Stat)
Creatine-filled swag bags and an embrace from Vance: MAHA marks its ascendance in Trump’s Washington (Stat)
At Hush-Hush MAHA Summit, Vance Praises RFK Jr. for Defying Convention (MedPageToday.com)
MAHA Summit Showcases Eclectic Coalition, Populist Health Messaging (InsideHealthPolicy Daily News)
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Inside Providence’s plan for 340B rebate disruption
Starting January 1, 2026, the 340B rebate pilot program, approved by HRSA, will shift from upfront discounts to post-sale rebates, affecting hospitals’ financial operations. Providence Health anticipates significant challenges, including cash flow issues and increased administrative burdens, as it adapts to this new model involving eight manufacturers, such as AstraZeneca and Merck. A recent analysis suggests that disproportionate share hospitals could face upfront costs exceeding $72 million if the rebate model expands, prompting Providence to develop risk mitigation strategies and advocate for stronger enforcement mechanisms to protect 340B program integrity.
Source(s):
Inside Providence’s plan for 340B rebate disruption (Becker’s Hospital Review)
Tags: #HOSPITAL, #DRUG
Major takeaways for federal agencies on the funding deal to reopen government
A recently passed spending package aims to reopen the federal government and includes provisions for various federal agencies, reaffirming backpay for furloughed employees and preventing layoffs through January 30, 2026. Notably, the appropriations bill provides $3.4 billion in discretionary funding for the FDA, maintaining operational levels amidst proposed cuts by the Trump administration. The deal also emphasizes oversight of USDA changes and staffing levels at the VA, reflecting a commitment to maintaining critical services during the funding lapse.
Source(s):
Major takeaways for federal agencies on the funding deal to reopen government (Government Executive)
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OPM’s retirement backlog skyrockets as deferred resignees begin offboarding
The Office of Personnel Management (OPM) faces a critical retirement claims backlog exceeding 34,000 applications, with processing delays averaging 79 days. This federal workforce crisis, stemming from deferred resignations under previous administration policies, threatens continuity of healthcare oversight operations at FDA and CMS, potentially impacting Medicare beneficiaries and pharmaceutical/medical device regulations. The surge in October 2025 claims (20,344 received vs 8,751 processed) signals broader implications for federal healthcare policy implementation and regulatory capacity.
Source(s):
OPM’s retirement backlog skyrockets as deferred resignees begin offboarding (Government Executive)
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Advocates Call for Legal Rights to Vaccinations for Children
Healthcare professionals advocate for legal protections ensuring children’s vaccination access, citing vaccines’ proven disease elimination success and affordability at 60 cents per dose. The proposal addresses vaccine hesitancy concerns while potentially impacting pharmaceutical distribution, FDA regulatory frameworks, and public health policy enforcement mechanisms affecting healthcare stakeholders.
Source(s):
Advocates Call for Legal Rights to Vaccinations for Children (Stat)
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Unions Challenge Loyalty Question for Federal Job Applicants
Unions have filed a lawsuit against the Trump administration’s requirement for federal job applicants to disclose their support for the president’s political priorities, arguing it undermines the nonpartisan nature of civil service positions. This legal challenge raises important questions about the politicization of federal employment processes and the implications for workforce integrity.
Source(s):
Unions Challenge Loyalty Question for Federal Job Applicants (InsideHealthPolicy Daily News)
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Kennedy Walks a Tightrope on Trump Deal for Obesity Drugs
Robert F. Kennedy Jr., U.S. Health Secretary, navigates political tensions over Trump administration’s obesity drug deal involving FDA approval pathways and Medicare coverage. The pharmaceutical policy dispute reveals internal divisions affecting drug accessibility, CMS reimbursement decisions, and broader healthcare stakeholder implications for obesity treatment access.
Source(s):
Kennedy Walks a Tightrope on Trump Deal for Obesity Drugs (The New York Times)
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NIH Official Behind ‘Bethesda Declaration’ Placed On Administrative Leave
Dr. Jenna Norton, NIH program director and architect of the ‘Bethesda Declaration’ criticizing federal research policies, was placed on administrative leave amid concerns over political interference in NIH operations. The action could impact pharmaceutical research funding, FDA regulatory processes, and Medicare-supported medical device studies, raising questions about scientific independence under current federal health policy direction and potential effects on healthcare stakeholders.
Source(s):
NIH Official Behind ‘Bethesda Declaration’ Placed On Administrative Leave (Stat)
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Trump Administration Prioritizes Information Blocking
The Trump administration is intensifying efforts to combat healthcare information blocking, with HHS proposing stricter 21st Century Cures Act enforcement. Violations by hospitals and device manufacturers could face up to $1 million fines. This CMS-backed initiative aims to improve patient data sharing, potentially impacting Medicare reimbursements and pharmaceutical data transparency across healthcare systems.
Source(s):
Trump Administration Prioritizes Information Blocking (Becker’s Hospital Review)
Tags: #ALL
Trump’s affordability push is speaking louder than his words
In response to electoral setbacks, President Trump has proposed affordability measures including $2,000 checks for low- and middle-income Americans to address rising healthcare and living costs. These policies could impact Medicare beneficiaries, hospital systems, and pharmaceutical access, though effectiveness remains uncertain amid ongoing economic challenges affecting healthcare stakeholders.
Source(s):
Trump’s affordability push is speaking louder than his words (POLITICO – TOP Stories)
Tags: #ALL
Heard on the Hill
House Democrats Introduce Legislation to Repeal CMS Medicare AI-Powered Prior Authorization Pilot Program
House Democrats have introduced legislation to roll back CMS’s Medicare prior authorization pilot program that utilizes AI-driven decision-making processes, citing significant administrative burdens on healthcare providers and delays in patient access to prescribed treatments, medical devices, and hospital services. The bipartisan pushback highlights growing tensions between lawmakers and CMS over the role of artificial intelligence technology in Medicare and Medicaid coverage decisions, with potential implications for pharmaceutical approvals and medical device access across federal healthcare programs. The legislative effort could fundamentally reshape prior authorization practices for Medicare beneficiaries and significantly impact provider workflows and patient care delivery systems.
Source(s):
House Dems make push to roll back CMS’ AI-powered prior auth model (Fierce Healthcare)
Democrats Introduce Bill to Repeal Medicare Prior Authorization Pilot (Healthcare Dive)
Tags: #ALL
Senate Republicans Secure Shutdown Victory Without ACA Subsidy Extension, Sparking Democratic 2026 Election Concerns
Following a 43-day government shutdown that ended November 12, 2025, Senate Republicans led by Majority Leader John Thune secured a bipartisan funding deal that reopened the government and restored over one million federal workers, but notably excluded extension of enhanced ACA subsidies set to expire at year-end. Eight Senate Democrats supported the measure despite progressive backlash against Minority Leader Chuck Schumer, with the decision potentially triggering premium increases exceeding 25% for millions of ACA marketplace enrollees and creating electoral vulnerabilities heading into 2026 midterms. The resolution extends healthcare programs including Medicare telehealth and hospital-at-home initiatives until January 30, 2026, while Republicans propose replacing ACA premium tax credits with direct cash payments, though conservative think tanks remain skeptical of the approach as CMS, FDA, and HHS operations resume normal regulatory oversight.
Source(s):
Schumer Faces Progressive Backlash Over Shutdown Deal (POLITICO – TOP Stories)
As Shutdown Nears End, Trump Still Confronts Soaring Health Costs (The New York Times)
Republicans need Trump for the debate on Obamacare credits (POLITICO)
House Democrats Propose Amendment for ACA Subsidies (Health Exec)
Senate Dems’ Move To Back CR Without ACA Subsidies Sparks 2026 Election Alarms As Premiums Set to Rise (InsideHealthPolicy Daily News)
Government shutdown ends: 5 healthcare notes (Becker’s Hospital Review)
GOP ACA proposal complicates negotiations (Stat)
The shutdown is ending, and House Democrats are furious (POLITICO)
Government to reopen after House votes to end longest-ever shutdown (Government Executive)
Republicans want to replace enhanced ACA tax credits with direct payments. Their think tank allies aren’t so sure (Stat)
Republicans win shutdown showdown—Senate agrees to funding deal without ACA subsidy extension (Health Exec)
How Senate Republicans won the last vote to end the shutdown (POLITICO – TOP Stories)
Democrats want to extend Obamacare credits. Republicans have other ideas. (POLITICO – TOP Stories)
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FAH President Warns of Healthcare Policy Shifts
Chip Kahn, president of the Federation of American Hospitals, expresses deep concern regarding recent healthcare policy changes, including potential Medicaid cuts and the expiration of ACA premium tax subsidies. He warns that these shifts could lead to a significant increase in the uninsured population and threaten the financial stability of hospitals, particularly as they navigate the complexities of the upcoming legislative landscape.
Source(s):
FAH President Warns of Healthcare Policy Shifts (Becker’s Hospital Review)
Tags: #ALL
Senate bill aims to close HIPAA gap for wearable health data
Senator Bill Cassidy’s Health Information Privacy Reform Act addresses HIPAA gaps for wearable device health data, requiring user notification of limited protections and opt-out rights. The legislation impacts healthcare providers, device manufacturers, and patients as wearable technology adoption accelerates, potentially affecting hospital data integration and FDA-regulated medical devices while addressing privacy concerns in digital health ecosystems.
Source(s):
Senate bill aims to close HIPAA gap for wearable health data (Becker’s Hospital Review)
Tags: #ALL
The next shutdown threat is around the corner
Following the recent government shutdown, Congress faces a January 30, 2026 budget deadline with unresolved funding for public health programs, Medicare operations, and ACA insurance subsidies. Potential impacts include disrupted CMS payments to hospitals, delayed FDA device approvals, and pharmaceutical supply chain concerns if bipartisan agreements fail, threatening another shutdown.
Source(s):
The next shutdown threat is around the corner (POLITICO)
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Republicans in Congress lukewarm on Trump idea of tariff rebate checks
President Trump’s proposal for $2,000 tariff rebate checks faces GOP resistance over fiscal concerns and inflation risks. While not directly targeting healthcare, such payments could affect Medicare beneficiaries and hospital systems through broader economic impacts. Republican lawmakers question funding sustainability despite administration claims of sufficient tariff revenue to support direct payments to Americans.
Source(s):
Republicans in Congress lukewarm on Trump idea of tariff rebate checks (POLITICO)
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Crapo Plans Hearing On Rising Health Costs, New Coalition Launches
Senate Finance Committee Chair Mike Crapo announced a hearing on rising healthcare costs, examining pharmaceutical pricing, Medicare reimbursements, and hospital expenses. The hearing coincides with ACA political developments as CMS and stakeholders seek policy solutions to address escalating costs impacting patients, providers, and federal programs.
Source(s):
Crapo Plans Hearing On Rising Health Costs, New Coalition Launches (InsideHealthPolicy Daily News)
Tags: #ALL
Trump’s Broadside Against Health Insurers is a Cautionary Tale for Industry
Health insurers face mounting pressure as Trump criticizes ACA implementation, creating uncertainty for Medicare plans and hospital networks. The political tension threatens industry partnerships with pharmaceutical companies and medical device manufacturers, while potentially triggering new CMS regulations and FDA oversight changes that could reshape healthcare delivery and reimbursement across all stakeholder sectors.
Source(s):
Trump’s Broadside Against Health Insurers is a Cautionary Tale for Industry (POLITICO – Health Care)
Tags: #ALL
Cassidy Continues FSA Campaign As Bipartisan Health Talks Ramp Up
Senate health committee chair Bill Cassidy (R-LA) is advocating for the integration of flexible spending accounts (FSAs) into health exchanges as part of ongoing bipartisan negotiations. This follows the Senate’s recent passage of a government funding deal on November 9, which notably did not extend the enhanced Affordable Care Act subsidies set to expire soon.
Source(s):
Cassidy Continues FSA Campaign As Bipartisan Health Talks Ramp Up (InsideHealthPolicy Daily News)
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Notable Notes
AMA Conference Reveals Deep Divisions Over Healthcare Reform Strategy as Organization Grapples with Policy Direction
At the recent AMA conference, physician delegates engaged in heated debates over fundamental healthcare reform approaches, including proposals to redirect ACA premium tax credits to health savings accounts and establish new vaccine advisory committees to restore CDC’s public health role. The discussions highlighted persistent divisions among medical stakeholders on Medicare reforms, CMS oversight, FDA regulations, and pharmaceutical policies, while the simultaneous closure of the AMA Journal of Ethics compounds challenges in maintaining unified ethical guidance for healthcare policy development. AMA leadership emphasized finding ‘common ground’ with federal agencies while maintaining advocacy positions that protect physician autonomy and patient care interests amid ongoing regulatory negotiations.
Source(s):
Do HSAs Make Insurance More Affordable? AMA Delegates Are Split on the Issue (MedPageToday.com – medical news for physicians)
Health Reform Continues to Roil AMA Members (MedPageToday.com – medical news for physicians)
AMA Delegates Consider Becoming ‘Public-Facing Megaphone’ on Vaccines (MedPageToday.com – medical news for physicians)
AMA President: Fight When Necessary, but Also Find ‘Common Ground’ (MedPage Today Meeting Coverage)
In Memoriam: The Sudden Demise of the AMA Journal of Ethics (MedPageToday.com)
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Interventional cardiology showing more interest in endovascular procedures
At the TCT 2025 conference, interventional cardiology’s shift towards endovascular procedures for stroke and pulmonary embolism highlights evolving clinical practices with significant implications for device manufacturers, FDA approval pathways, hospital procedural capabilities, and Medicare reimbursement policies. This trend may drive new training requirements, affect pharmaceutical partnerships, and influence CMS coverage decisions for emerging endovascular technologies across cardiovascular specialties.
Source(s):
Interventional cardiology showing more interest in endovascular procedures (Cardiovascular Business)
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Joint Commission Appoints New Deputy Chief Medical Officer
The Joint Commission has appointed Arjun Srinivasan, MD, as deputy chief medical officer to lead healthcare quality and safety initiatives. With 25+ years at CDC, Dr. Srinivasan will enhance hospital accreditation standards, potentially impacting Medicare reimbursement, CMS compliance, and FDA device regulations across healthcare systems.
Source(s):
Joint Commission Appoints New Deputy Chief Medical Officer (Becker’s Hospital Review)
Tags: #HOSPITAL, #PROVIDER
Hospital innovations creating value — without major new spending
UChicago Medicine’s patient advocacy program reduced nonurgent emergency department visits by 45% through cost-effective navigation initiatives, demonstrating hospital operational efficiency improvements without major spending. This model offers policy implications for Medicare reimbursement optimization and CMS value-based care frameworks, potentially reducing healthcare costs while improving patient outcomes and hospital resource allocation.
Source(s):
Hospital innovations creating value — without major new spending (Becker’s Hospital Review)
Tags: #HOSPITAL, #PAYER, #PATIENT
Yale Team Wants to Democratize Data With PopHIVE
Researchers at Yale University are developing PopHIVE, a data dashboard to enhance public health decision-making by democratizing health data access for hospitals, healthcare stakeholders, and policy makers. This initiative addresses data utilization gaps exposed during COVID-19, potentially informing future FDA guidance and CMS Medicare policies for improved healthcare system preparedness and population health management.
Source(s):
Yale Team Wants to Democratize Data With PopHIVE (MedPageToday.com)
Tags: #HOSPITAL, #PAYER, #PROVIDER
Pfizer signals brewing digital health work
Pfizer’s digital medicine strategy lead hiring signals pharmaceutical industry shift toward FDA-regulated digital therapeutics integration. New PDURS Center of Excellence could enable device-drug combination products under FDA’s 2023 guidance, potentially expanding Medicare reimbursement pathways and hospital adoption of prescription-linked digital health tools for improved patient outcomes.
Source(s):
Pfizer signals brewing digital health work (Stat)
Tags: #ALL
Health systems strengthen AI gatekeepers
At a recent conference, healthcare leaders emphasized critical AI governance roles within hospital systems, discussing FDA oversight frameworks and CMS compliance for AI medical devices. They focused on ethical transparency, patient consent, and Medicare reimbursement implications, ensuring pharmaceutical and healthcare innovations meet regulatory standards for safe, effective patient care while addressing stakeholder impacts across health systems.
Source(s):
Health systems strengthen AI gatekeepers (Becker’s Hospital Review)
Tags: #ALL
Multi-Cancer Testing Could Transform Cancer Diagnosis, Study Suggests
A modeling study indicates that annual supplemental multi-cancer early detection (MCED) testing could significantly lower late-stage cancer diagnoses over a decade. This device-based approach could impact Medicare coverage decisions and require FDA regulatory oversight, potentially influencing patient outcomes, healthcare costs, and hospital cancer care protocols across healthcare systems.
Source(s):
Multi-Cancer Testing Could Transform Cancer Diagnosis, Study Suggests (MedPage Today Primary Care)
Tags: #ALL
A new alternative: Surgeons, cardiologists gather to learn about robotic aortic valve replacement
The WVU Heart and Vascular Institute hosted a symposium on robotic aortic valve replacement, a FDA-regulated device innovation offering hospitals a safe alternative to TAVR and SAVR for severe aortic stenosis patients. This technology could impact Medicare reimbursement protocols and reshape cardiac treatment standards across healthcare systems.
Source(s):
A new alternative: Surgeons, cardiologists gather to learn about robotic aortic valve replacement (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #HOSPITAL
The Results Are In: AI in Healthcare is Working
Over 80% of healthcare organizations are implementing AI projects, with notable successes in revenue cycle management, including faster Medicare reimbursements and reduced CMS denial rates. However, only 18% have mature strategies for scaling these technologies across hospitals and pharmaceutical sectors. This implementation gap suggests need for FDA guidance and standardized policies to maximize AI benefits for healthcare stakeholders while ensuring regulatory compliance and patient safety.
Source(s):
The Results Are In: AI in Healthcare is Working (Becker’s Hospital Review)
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Siemens Healthineers and Boston Scientific Partner on Next-Generation Intracardiac Echo for LAAO
Siemens Healthineers and Boston Scientific have partnered to develop a next-generation intracardiac echo device for left atrial appendage occlusion procedures, with Boston Scientific as exclusive distributor. This medical device collaboration could impact hospital cardiac care efficiency, potentially affecting Medicare reimbursements and requiring FDA approval for clinical implementation.
Source(s):
Siemens Healthineers and Boston Scientific Partner on Next-Generation Intracardiac Echo for LAAO (Cardiovascular Business)
Tags: #DEVICE, #HOSPITAL, #PROVIDER
Pharma Can’t Stop Buying Biotechs
Merck’s $9.2 billion Cidara Therapeutics acquisition and Pfizer’s $10 billion Metsera purchase highlight pharmaceutical industry consolidation amid patent cliff pressures. These biotech acquisitions signal strategic shifts toward obesity therapeutics, potentially impacting Medicare coverage decisions, FDA approval pathways, and hospital formulary access as companies rebuild revenue pipelines through portfolio expansion.
Source(s):
Pharma Can’t Stop Buying Biotechs (Stat)
Tags: #ALL
Funding Uncertainty Is Hurting U.S. Health Research
The U.S. health research sector faces significant funding uncertainties, threatening pharmaceutical development, medical device innovation, and hospital-based studies. Stakeholders urge Congressional action to stabilize NIH and FDA research support, as instability could impact Medicare beneficiaries and delay CMS evidence-based policy decisions critical for advancing patient care.
Source(s):
Funding Uncertainty Is Hurting U.S. Health Research (MedPageToday.com)
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Pfizer to Sell $508M Stake in BioNTech
Pfizer plans to divest its remaining $508M BioNTech stake, signaling strategic pharmaceutical portfolio shifts in post-pandemic markets. This move could impact future vaccine development partnerships and FDA-regulated drug pricing strategies, affecting hospital procurement costs and Medicare coverage decisions for innovative therapeutics.
Source(s):
Pfizer to Sell $508M Stake in BioNTech (Becker’s Hospital Review)
Tags: #DRUG, #HOSPITAL, #PAYER
Aetna, Cigna ‘Downcoding’ Policies Receive Pushback from States
States like Arkansas and Virginia are enacting laws to limit controversial downcoding practices by major insurers Aetna and Cigna, which healthcare providers claim unfairly reduce hospital and physician reimbursements. This legislative push reflects growing regulatory concerns about transparency in medical billing practices, potentially impacting Medicare and commercial insurance reimbursement structures while addressing provider-payer disputes over coding accuracy.
Source(s):
Aetna, Cigna ‘Downcoding’ Policies Receive Pushback from States (modernhealthcare.com)
Tags: #PROVIDER, #PAYER, #HOSPITAL
Military Families Show Strength in Community Engagement, Workplace Confidence and Resilience
Research indicates military families exhibit resilience and strong community engagement, with 67% feeling enthusiastic about their jobs. However, they face significant health challenges, including higher chronic condition prevalence. This highlights need for targeted Medicare support services, CMS policy adaptations, and enhanced healthcare access through military hospitals and pharmaceutical programs to address unique healthcare disparities affecting this population.
Source(s):
Military Families Show Strength in Community Engagement, Workplace Confidence and Resilience (newsroom.thecignagroup.com)
Tags: #PATIENT, #PAYER, #PROVIDER
What Pfizer’s Metsera deal means for biotech M&A
Pfizer’s $10 billion acquisition of weight loss drug developer Metsera strengthens its obesity treatment pipeline and signals robust pharmaceutical M&A activity. The deal highlights FDA-approved obesity therapeutics’ growing market value, potentially impacting Medicare coverage decisions and healthcare cost management strategies for payers and providers.
Source(s):
What Pfizer’s Metsera deal means for biotech M&A (Stat)
Tags: #DRUG, #PAYER, #ALL