Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS Innovation Center’s AI-Assisted Prior Authorization Model Faces Political Opposition As Industry Develops Standards
The CMS Innovation Center’s WISeR model, implementing AI-assisted prior authorization for Medicare services starting in 2026, has become a political flashpoint with Democratic lawmakers raising concerns about patient access. CMMI responded with FAQs assuring healthcare provider oversight of AI decisions and chief actuary evaluation before expansion. Meanwhile, the Coalition for Health AI will release draft standards for AI-supported prior authorization within six months, coordinating with CMMI to streamline workflows. Rep. Alexandria Ocasio-Cortez submitted additional concerns to CMS regarding the initiative.
Source(s):
CHAI To Release Prior Auth Standards As CMMI Expands Prior Auth In FFS Medicare (InsideHealthPolicy Daily News)
CMMI’s AI-Assisted Prior Authorization Model Becomes New Political Lightning Rod (InsideHealthPolicy Daily News)
CMMI Addresses Some Democratic WISeR Model Worries In FAQ, Comments (InsideHealthPolicy Daily News)
Letter to CMS on Wiser (ocasio-cortez.house.gov)
Tags: #ALL
Multiple Fronts of Medicare Payment Cuts Threaten Healthcare Provider / Hospital Financial Stability
Healthcare providers face a convergence of Medicare payment reduction threats spanning multiple policy mechanisms. The Congressional Budget Office warns that Trump-era tax law deficits could trigger automatic Medicare cuts under statutory spending controls. Simultaneously, CMS faces criticism over proposed 2026 Medicare Physician Fee Schedule changes and a $7.8 billion reduction in outpatient facility payments that could significantly impact hospital reimbursement rates. The Medical Group Management Association warns these modifications could reduce Medicare reimbursement and limit patient access to physician services, while a University of Washington study contradicts CMS evidence supporting proposed surgery reimbursement cuts, raising questions about the policy basis for reducing surgical procedure payments and overall healthcare provider financial sustainability.
Source(s):
Medicare Cuts Loom Due to Trump Tax Law, CBO Warns (MedPageToday.com)
MGMA Raises Concerns Over Proposed Medicare Fee Schedule Changes (Health Exec)
Proposed Medicare Cuts to Outpatient Payments Explained (Modern Healthcare)
UW Study Contradicts CMS Basis for Surgery Reimbursement Cuts (The Black Chronicle)
Tags: #PROVIDER, #HOSPITAL, #PAYER
Leaders split on CMS proposal to eliminate inpatient-only list
CMS’s proposal to eliminate the inpatient-only list for certain musculoskeletal procedures has divided healthcare leaders, with implications for hospital reimbursement and Medicare payment structures. The policy change would affect where these procedures can be performed and how health systems receive compensation, sparking debate over patient access and care delivery models.
Source(s):
Leaders split on CMS proposal to eliminate inpatient-only list (Becker’s Hospital Review)
Tags: #HOSPITAL, #PROVIDER, #PAYER
New CMS data suggest future ACA market turmoil as feds crack down on fraud
Recent CMS data reveal potential ACA marketplace instability as federal authorities intensify fraud enforcement efforts, raising concerns about insurance coverage disruptions, health plan participation, and patient access to affordable care options through the federal exchanges.
Source(s):
New CMS data suggest future ACA market turmoil as feds crack down on fraud (Fierce Healthcare)
Tags: #PAYER, #PATIENT, #PROVIDER
Clock ticks for hospitals as TEAM bundled payment model nears
The TEAM bundled payment model implementation approaches, prompting hospitals to urgently adapt their Medicare payment and hospital reimbursement structures. This CMS initiative represents a significant shift in healthcare provider compensation frameworks, requiring health systems to modify financial operations and potentially impacting patient care delivery models as the healthcare industry transitions toward value-based payment systems.
Source(s):
Clock ticks for hospitals as TEAM bundled payment model nears (Modern Healthcare)
Tags: #HOSPITAL, #PROVIDER, #PAYER
AdvaMed Commends CMS for New Healthcare Data Sharing Initiative
AdvaMed has praised the Centers for Medicare & Medicaid Services (CMS) for launching a new healthcare data sharing initiative designed to improve healthcare delivery and patient outcomes. The medical device industry association commended the policy as a step toward better care coordination and health system efficiency through enhanced data interoperability.
Source(s):
AdvaMed Commends CMS for New Healthcare Data Sharing Initiative (Medical Device Network)
Tags: #DEVICE, #PROVIDER, #PAYER
Food and Drug Administration (FDA)
Medical Device User Fee Negotiations Kick Off
The medical device sector faces mounting tensions over FDA user fee structures under the Medical Device User Fee Act (MDUFA), with industry representatives from AdvaMed praising current regulatory progress while questioning future growth trajectories for device manufacturers. Simultaneously, patient advocates are demanding increased device user fees to maintain adequate post-market safety monitoring following recent FDA layoffs of officials responsible for medical device regulation and patient safety assessments. The competing pressures highlight ongoing debates over FDA clearance processes, regulatory oversight funding, and the balance between industry development timelines and patient safety requirements.
Source(s):
Industry Praises Progress, Questions Growth At MDUFA Meeting (InsideHealthPolicy Daily News)
Patient Advocates: Higher Device User Fees Needed After FDA Layoffs (InsideHealthPolicy Daily News)
Tags: #DEVICE, #PATIENT
Healthcare AI Integration Accelerates with 38.5% Market Growth Amid Rising Concerns Over Provider Skill Degradation and Regulatory Oversight
The healthcare AI market is experiencing explosive 38.5% annual growth as diagnostic technologies gain FDA approval and become embedded in nearly every cardiovascular IT system. However, medical research reveals concerning “deskilling” effects among healthcare providers, with endoscopists showing declining unassisted detection rates after AI adoption. This rapid integration is forcing healthcare systems to develop new implementation strategies and staff training programs while raising urgent questions about physician-patient relationships, regulatory oversight complexities, and patient safety considerations as AI-enabled diagnostic tools become standard in medical practice.
Source(s):
Healthcare AI Market Explodes 38.5% Annually as Diagnostics Gain FDA Traction (The Globe and Mail)
AI now embedded in nearly every cardiovascular IT system (Cardiovascular Business)
As AI spreads through health care, is the technology degrading providers’ skills? (Stat)
Medicine’s AI era urgently demands new doctor-patient relationship (Stat)
OpenAI can’t have it both ways on GPT-5 and health (Stat)
Tags: #ALL
Dear Vinay: Please embrace dissent and fade into the background
Following his controversial tenure and brief departure, Vinay Prasad’s return to the FDA highlights ongoing debates over vaccine policies and regulatory decision-making. The article emphasizes the need for collaborative leadership within the agency, suggesting Prasad should prioritize listening to stakeholders and allowing FDA achievements in pharmaceutical approvals and public health initiatives to take precedence over individual visibility.
Source(s):
Dear Vinay: Please embrace dissent and fade into the background (Stat)
Tags: #DRUG, #PROVIDER, #PATIENT
Medtech company raises $32M to expand research on foam-based LAAO device
Conformal Medical, a New Hampshire-based medical device manufacturer, raised $32 million to advance clinical trials for its foam-based left atrial appendage occlusion (LAAO) device. The funding will support patient enrollment in ongoing studies evaluating the device’s safety and effectiveness in preventing strokes for atrial fibrillation patients. This investment highlights growing interest in innovative medical devices that could improve patient outcomes and potentially reduce healthcare costs associated with stroke prevention. The device, if successful in trials, would require FDA clearance before market availability, representing another advancement in cardiovascular medical device technology for healthcare providers treating patients with atrial fibrillation.
Source(s):
Medtech company raises $32M to expand research on foam-based LAAO device (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #PATIENT
FDA regulator reinstalled less than two weeks after White House ouster
The FDA leadership disruption, with a regulator’s ouster and reinstatement within two weeks, underscores regulatory instability that could impact FDA approval processes, pharmaceutical oversight, and public confidence in drug safety decisions. Such rapid administrative changes may affect the agency’s ability to maintain consistent regulatory standards and stakeholder trust.
Source(s):
FDA regulator reinstalled less than two weeks after White House ouster (The Washington Post)
Tags: #DRUG, #DEVICE, #ALL
The FDA’s Absence from International Standards Meetings Threatens U.S. Leadership
The FDA’s reduced participation in international medical device and pharmaceutical standards development meetings undermines U.S. regulatory leadership and creates uncertainty for device manufacturers and pharmaceutical companies. This absence threatens patient safety protocols, medical innovation pathways, and cybersecurity standards while potentially diminishing predictable FDA approval and clearance processes that manufacturers rely on for bringing products to market.
Source(s):
The FDA’s Absence from International Standards Meetings Threatens U.S. Leadership (Stat)
Tags: #DEVICE, #DRUG
Health and Human Services
MAHA Initiative Evolution: From Comprehensive Assessment to Draft Report Emphasizing Education Over Regulation
The Make America Healthy Again initiative has evolved significantly since the White House’s initial comprehensive assessment in January, which evaluated proposals across food safety, pharmaceutical regulation, and environmental health. Recent developments reveal a strategic shift as HHS Secretary Robert F. Kennedy Jr.’s draft MAHA report emphasizes education and research over regulatory action, notably avoiding new pesticide regulations and food/farming restrictions despite earlier comprehensive policy evaluations. The initiative faces mounting challenges following a CDC shooting linked to anti-vaccine sentiment, intensifying scrutiny on public health policy direction. The draft strategy focuses on nutrition and agricultural chemical research while offering limited concrete policy recommendations or implementation frameworks, potentially constraining federal action on pressing health issues and impacting CDC operations, vaccine programs, and healthcare provider guidance under the administration’s health agenda.
Source(s):
White House Releases Comprehensive MAHA Assessment Report (White House)
Challenges mount for RFK Jr. and his MAHA agenda (Stat)
Draft of ‘Make America Healthy Again’ Report Suggests RFK Jr. Won’t Push Pesticide Regulations (The New York Times)
Draft MAHA Strategy Avoids New Regulations on Food and Farming (POLITICO)
Draft of major MAHA report calls for more education, less regulation — and offers few policies (Stat)
Key takeaways from draft MAHA report (Stat)
Tags: #ALL
Trump Administration’s NIH Budget Cuts and Political Oversight Disrupt Federal Health Research Funding
The Trump administration’s significant budget reductions to the National Institutes of Health have substantially curtailed federally-funded research programs, particularly those targeting health disparities in underserved populations. Political interference and new bureaucratic oversight layers have created substantial delays in research grant approvals, disrupting traditional scientific funding mechanisms and affecting staff morale. These challenges impact healthcare innovation, patient access to new treatments, and academic medical institutions dependent on NIH funding. Despite recent bipartisan budget increases, the funding cuts affect CDC, NIH, and other health agencies, though advocates see potential for improved support that could restore medical research capabilities.
Source(s):
With Deep N.I.H. Cuts, Research Into Health Disparities Falters (The New York Times)
How Many Times Can Science Funding Be Canceled? (The Atlantic)
With U.S. Funding for Science at Risk, Advocate Sees ‘Light at the End of the Tunnel’ (Stat)
Layers of Political Oversight Have ‘Put Sand in the Gears’ of NIH Grant Funding (Stat)
Tags: #ALL
Trump administration’s vaccine policy overhaul sparks scientific controversy and industry uncertainty
The Trump administration’s sweeping vaccine policy changes under HHS Secretary Robert F. Kennedy Jr. have triggered widespread controversy across multiple fronts. Kennedy called for retracting a Danish study of 1.2 million children showing no vaccine-autism link, with the medical journal refusing and defending the research as valid science. The administration terminated $500 million in federal mRNA vaccine development contracts, with NIH Director Jay Bhattacharya citing public distrust as justification, though Kennedy’s own cited evidence contradicted his anti-vaccine position. The funding cuts are heightening pharmaceutical investor caution in mRNA vaccine development while leaving cancer therapeutics unaffected. Political tensions reached a peak when Trump’s Chief of Staff intervened to reinstate Kennedy’s top vaccine policy aide after pharmaceutical industry lobbying attempted their removal, highlighting ongoing struggles between vaccine policy, scientific evidence, industry influence, and federal health regulation under the new administration.
Source(s):
Medical journal bucks RFK, refuses to retract Danish vaccine study (Health Exec)
Another explanation for canceled mRNA contracts (Stat)
Kennedy’s case against mRNA vaccines collapses under his own evidence (Stat)
Trump administration leaves biotech investors more wary than ever of funding mRNA vaccines (Stat)
Trump’s chief intervened to save RFK Jr.’s top vaccine aide (POLITICO)
Tags: #ALL
American Medical Association Shifts to Confrontational Strategy Against Trump Healthcare Policies
The American Medical Association is dramatically pivoting from quiet lobbying to vocal public opposition against Trump administration healthcare policies. The strategic shift addresses concerns over potential changes to CMS reimbursement rules, HHS regulatory frameworks, and policies affecting physician autonomy and medical practice regulations. This transformation reflects growing physician frustration with ineffective behind-the-scenes advocacy and represents a significant escalation in healthcare provider relations with federal agencies. The AMA’s more confrontational stance could substantially influence future medical practice policies and patient care quality standards.
Source(s):
Inside the American Medical Association’s sudden strategy shift in Washington (Stat)
Doctor lobby becomes more vocal on Trump’s policies (Stat)
Tags: #PROVIDER, #PATIENT, #PAYER
Patient seeking care at NIH hospital detained by ICE
A patient receiving care at the NIH Clinical Center was detained by ICE officers after her state driver’s license failed to meet federal identification requirements. The incident highlights critical patient access concerns regarding immigration enforcement policies at federal healthcare facilities and potential barriers to care for vulnerable populations seeking treatment at government medical centers.
Source(s):
Patient seeking care at NIH hospital detained by ICE (Washington Post)
Tags: #PATIENT, #HOSPITAL
NIH to reject research applications written by AI
The NIH announced it will reject research grant applications substantially developed by artificial intelligence, citing concerns over originality and research misconduct. This policy affects healthcare researchers and medical institutions seeking federal funding, aiming to preserve research integrity and ensure authentic scientific contributions from physicians and healthcare providers in the grant application process.
Source(s):
NIH to reject research applications written by AI (Becker’s Hospital Review)
Tags: #PROVIDER, #DEVICE, #DRUG
Hospital groups push for more time to weigh in on HRSA 340B pilot program
Hospital groups including the American Hospital Association are requesting HRSA extend the comment period beyond seven days for its 340B drug discount program rebate model pilot, citing insufficient time for stakeholders to provide meaningful feedback on proposed changes to hospital reimbursement and pharmaceutical pricing mechanisms that could significantly impact patient access to discounted medications.
Source(s):
Hospital groups push for more time to weigh in on HRSA 340B pilot program (Becker’s Hospital Review)
Tags: #DRUG, #HOSPITAL, #PATIENT
The Executive Order That Could Cripple Science
An executive order signed by President Trump threatens to dismantle U.S. scientific infrastructure, potentially impacting federal health research programs, CDC public health initiatives, and FDA regulatory science. The policy could affect healthcare provider access to research data, patient access to evidence-based treatments, and federal agency coordination on health outcomes research and medical practice guidelines.
Source(s):
The Executive Order That Could Cripple Science (MedPageToday.com)
Tags: #ALL
Judge blocks HHS from sharing Medicaid data with ICE
A federal judge has temporarily blocked HHS from sharing Medicaid beneficiary data with Immigration and Customs Enforcement (ICE), following a multi-state lawsuit led by California challenging the data-sharing policy. The ruling protects patient access and healthcare privacy for Medicaid enrollees while the legal challenge proceeds.
Source(s):
Judge blocks HHS from sharing Medicaid data with ICE (Becker’s Hospital Review)
Tags: #PATIENT, #PROVIDER, #PAYER
Staff cuts are undermining federal research on how to make health care better
Staff cuts at the Agency for Healthcare Research and Quality (AHRQ) have significantly reduced its capacity to distribute research grants and support healthcare improvement studies, potentially impacting care quality research and health outcomes measurement that inform federal health policy decisions.
Source(s):
Staff cuts are undermining federal research on how to make health care better (Stat)
Tags: #PATIENT, #PROVIDER, #HOSPITAL
CDC Employees Face Layoffs, Vaccine Misinformation, and Violence | CDC Shooting Sparks Concerns Abou…
CDC faces workforce crisis with nearly 3,000 employee departures since 2017, as staff confront job insecurity, safety threats including violence at Atlanta headquarters, and challenges from vaccine misinformation. The staffing losses impact CDC operational capacity and public health emergency preparedness, affecting healthcare provider guidance and patient access to reliable health information during critical health crises. A shooting at CDC headquarters on August 8 that killed a police officer is being characterized by public health experts as an attack on public health institutions comparable to the January 6 Capitol riots. The incident has raised widespread concerns about escalating political violence targeting federal health agencies and their personnel.
Source(s):
CDC Employees Face Layoffs, Vaccine Misinformation, and Violence (Government Executive)
CDC Shooting Viewed as Public Health’s January 6th (Stat)
Opinion: The CDC shooting was public health’s Jan. 6 (Stat)
Tags: #PROVIDER, #PATIENT, #HOSPITAL
Can Trump finally ‘kill the clipboard’ in healthcare? | HHS Releases Updated Privacy FAQs For Intero…
The Trump administration’s healthcare interoperability initiative seeks to streamline patient access to medical records by eliminating paper-based processes, allowing digital authorization for healthcare providers and health systems to share patient data more efficiently across medical practices and reducing administrative burden.
Source(s):
Can Trump finally ‘kill the clipboard’ in healthcare? (Becker’s Hospital Review)
HHS Releases Updated Privacy FAQs For Interoperability Efforts (InsideHealthPolicy Daily News)
Tags: #HOSPITAL, #PROVIDER, #PATIENT
Heard on the Hill
CBO Analysis Reveals Public Law 119-21 Creates Healthcare Access Disparities Despite $3.3T Resource Increase
Congressional Budget Office analysis of Public Law 119-21 (One Big Beautiful Bill) projects $3.3 trillion in increased household resources through 2034, but reveals significant healthcare equity concerns. Despite overall resource gains, Medicaid and SNAP cuts will reduce resources for lowest-income Americans, leading to 10 million uninsured by 2034. The legislation creates concerning distributional effects with lower-income households facing net resource decreases, highlighting major disparities in healthcare access and nutrition assistance across socioeconomic levels from 2026-2034.
Source(s):
Distributional Effects of Public Law 119-21 (cbo.gov)
CBO Again Projects 10 Million Uninsured By 2034 Due To OBBB (InsideHealthPolicy Daily News)
Tags: #PATIENT, #PAYER, #PROVIDER
Under fire, GAO explains its mission to Congress
The Government Accountability Office (GAO), Congress’s independent auditor, faces criticism from the Trump administration and House Republicans who proposed a 50% budget cut. GAO defended its $811.9 million fiscal 2024 budget, noting 95% of its work is congressionally mandated and claims to save taxpayers $66.7 billion through oversight of federal programs including healthcare agencies like CMS, FDA, and HHS operations.
Source(s):
Under fire, GAO explains its mission to Congress (Government Executive – All Content)
Tags: #ALL
Notable Notes
AI-Powered Real-Time Prior Authorization Emerges as Healthcare Administrative Solution
Healthcare technology company Abridge is partnering with major health systems including Highmark Health and Allegheny Health Network to integrate real-time prior authorization capabilities into AI medical scribe technology. This innovation enables insurance coverage decisions during patient visits, addressing longstanding administrative burdens that delay treatment approvals and compromise patient access to care. The partnerships represent a significant shift toward AI-driven solutions for streamlining healthcare workflows, potentially reducing costs for health systems while improving care quality by eliminating traditional prior authorization delays that often impede physician efficiency and patient outcomes.
Source(s):
Prior auth plot twist: Highmark Health, AHN and Abridge go real-time (Becker’s Hospital Review)
Abridge adds live prior authorization to its AI scribe with Righmark Health (Stat)
Tags: #ALL
Judge orders White House budget office to reveal information about spending decisions
A federal court ordered the White House Office of Management and Budget (OMB) to restore a website detailing federal spending decisions that was removed in March, following concerns from journalists about OMB withholding appropriated funds. The ruling reinforces Congressional appropriations authority and government transparency requirements for federal expenditures, including healthcare and social program funding decisions that impact public access to services.
Source(s):
Judge orders White House budget office to reveal information about spending decisions (Government Executive – All Content)
Tags: #ALL
Larry Ellison Wants to Do Good, Do Research and Make a Profit
Oracle co-founder Larry Ellison is directing resources toward a research institute and for-profit health ventures targeting global health challenges. The initiatives represent private sector investment in health innovation and research, potentially impacting healthcare delivery and patient outcomes through technology-driven solutions.
Source(s):
Larry Ellison Wants to Do Good, Do Research and Make a Profit (The New York Times)
Tags: #DEVICE, #DRUG, #PROVIDER
Medication Prior Authorization Biggest Daily Challenge for 1 in 5 Prescribers, Survey Says
A recent survey reveals medication prior authorization creates significant daily administrative burdens for one in five healthcare providers, highlighting ongoing challenges in prescription drug access and physician workflow efficiency. The findings underscore persistent barriers between pharmaceutical prescribing decisions and insurance coverage requirements that impact medical practice operations and potentially patient care delivery.
Source(s):
Medication Prior Authorization Biggest Daily Challenge for 1 in 5 Prescribers, Survey Says (Managed Healthcare Executive)
Tags: #PROVIDER, #DRUG, #PAYER
Employers Project 10% Rise in Healthcare Costs for 2026
A survey by the International Foundation of Employee Benefit Plans shows employers expect healthcare costs to rise 10% in 2026, driving increases in employee premiums and health plan expenses. The projected cost escalation will impact employer-sponsored insurance coverage and employee benefit structures across health systems.
Source(s):
Employers Project 10% Rise in Healthcare Costs for 2026 (Managed Healthcare Executive)
Tags: #ALL
Advanced Risk Score Predicts Long-Term Survival After Mitral Valve Surgery
A new analysis shows the Society of Thoracic Surgeons Risk Calculator can effectively predict long-term patient outcomes after mitral valve surgery, potentially improving care quality and informing post-surgical management strategies. The medical device assessment tool, traditionally used for short-term risk evaluation, may help healthcare providers better assess patient access to optimal surgical interventions and long-term health outcomes.
Source(s):
Advanced Risk Score Predicts Long-Term Survival After Mitral Valve Surgery (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #HOSPITAL
How Clinicians Write About Black Patients in the EHR
A study published in Stat examines how clinicians document information about Black patients in electronic health records, revealing potential disparities in clinical documentation that could impact care quality and health outcomes. The research highlights the need for improved physician training and awareness in healthcare provider documentation practices to ensure equitable patient care across health systems.
Source(s):
How Clinicians Write About Black Patients in the EHR (Stat)
Tags: #PATIENT, #PROVIDER, #HOSPITAL
Opinion: States Should Ban PBM-Owned Pharmacies
Arkansas enacted legislation prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies, effective 2026, addressing concerns about vertical integration in prescription drug supply chains. The policy aims to reduce conflicts of interest that may impact drug pricing and patient access to medications.
Source(s):
Opinion: States Should Ban PBM-Owned Pharmacies (MedPageToday.com)
Tags: #DRUG, #PAYER, #PATIENT
Eli Lilly pushes back on proposed tariffs
Eli Lilly opposes President Trump’s proposed pharmaceutical tariffs of up to 250%, warning they would increase prescription drug pricing and reduce patient access to medications. The company, which has invested over $50 billion in U.S. manufacturing since 2020, advocates for systemic drug pricing reforms instead of tariff-based approaches that could impact healthcare costs and pharmaceutical supply chains.
Source(s):
Eli Lilly pushes back on proposed tariffs (Becker’s Hospital Review)
Tags: #DRUG, #PATIENT, #PAYER